GHTF Eyes 2013 for Relaunch, Some Devicemakers Wary

A new regulator-only Global Harmonization Task Force (GHTF) is expected in 2013, as the previous task force’s study groups will finish up their work through the end of next year.

The mechanics of how the new group will operate will also be worked out over that time.

During a three-day closed-door meeting in May in Brisbane, Aus-tralia, regulators assured devicemakers “industry engagement with the new group will be timely and substantive,” Janet Trunzo, vice president of technology and regulatory affairs at AdvaMed, told IMDRM.

The U.S. Food and Drug Administration (FDA) echoed those senti-ments. “Industry is a significant stakeholder in the process and agrees that their input to the harmonization effort is vital for continued success,” Lillian Gill, senior associate director for an FDA division told IMDRM.

However, some devicemakers are skeptical this will be the case. “I’ve never expressed optimism and I don’t know who has,” David Fisher, executive director of the Medical Imaging & Technology Alli-ance told IMDRM.

Decisions about the forum’s title and structure are still in the early stages of discussion, GHTF Chair Larry Kelly told IMDRM. As of now, the founding regulatory members of the GHTF — the FDA and regu-latory agencies of the EU, Japan, Canada and Australia — are seeking to include regulators from Brazil, Russia, India and China in the new body, Anne Trimmer, CEO of the Medical Technology Association of Australia, told IMDRM.

Moving forward, industry plans to create additional opportuni-ties for its voice to be heard as the new forum structure is hammered out, Fisher said. He is hopeful regulators will take advantage of the opportunities.

In March, after nearly two decades of working together on the task force, regulators told industry it was “time to begin a new phase” by creating a regulators-only forum (IMDRM, April).

Questions about how to use the regulatory documents developed by the task force must be answered by “regulator discussion, agenda set-ting and priority emphasis,” an FDA spokeswoman said at the time.

GHTF Eyes 2013 for Relaunch, Some Devicemakers Wary ................................................ 1

EU Physicians Want U.S. FDA-Style System for Device Evaluation ........................................... 2

More Trade Groups Sign Agreement On Ethical Interactions With HCPs................................. 3

APEC Endorses KL Principles for Device Sector Codes of Ethics .......................................... 3

NICE Guides to Help Speed Up Product Listings in NHS ................................................... 4

Brazil Improves Device Assessment For National Health System .............................................. 4

Eucomed Outlines Key Points For eHealth Uptake ............................................................ 5

Eucomed: Industry UDI Concerns Include Cost, Deviations in Use ........................................ 5

EC Refers Spain to Court of Justice For Illegal Device VAT Rate ............................................. 6

New Conduct Code for NBs To Improve CE Mark Use ................................................. 6

UK’s MHRA Defends NB, Device Regulatory System ................................................ 7

Increase in UK Recalls Sparks Requests for Transparency ............................................... 8

TGA Updates Its Risk-Management Approach for Regulating Devices .................................... 8

U.S. FDA Seeks Comments on Regulations With Demonstrated Deficiencies ...................................... 9

U.S. FDA Guidance Covers Delivery Devices for OTC Liquid Medicine ................................... 9

U.S. FDA Guidance Gives Reprocessing Instructions for Reusable Devices .................................. 10

U.S. FDA Draft Guidance Outlines Study Requirements for STD IVD Tests .................................. 10

U.S. FDA Seeks Postapproval Hip Implant Studies ........................................................ 11

Dues Could Fund Network for U.S. FDA Postmarket Surveillance System .................................... 11

U.S. FDA May Double User Fees Under Reauthorized MDUFMA ..................................... 13

Document Index:

Code of Conduct for EU Notified Bodies ............................................................ A

INTERNATIONAL MEDICAL DEVICE REGULATORY

A Monthly Alert to RegulationsAffecting the Medical Device

and Diagnostic Industries MONITORin this issue

Volume 19, Number 6 June 2011

www.medicaldevicemonitor.com

INTERNATIONAL MEDICAL DEVICE REGULATORY MONITORJune 2011

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Industry has expressed concern about the change, as it is manufacturers that must comply with the regulations. If manufacturer input is not a large part of the process, the resulting regulations may be focused on what is convenient for the regulators, not manufacturers, Fisher said at the time.

Regulators have had questions about the split as well. For example, it is unclear what will happen with memoran-dums of understanding (MOU) signed by the GHTF with other organizations, Kim Trautman, medical device quality system expert at the FDA, said recently.

One MOU in particular covers a standard for a compre-hensive management system for device design and manu-facture. The agreement allowed GHTF representatives to participate and have a voice in meetings of the technical committee that updates the standard. It is unclear whether the agreement will be maintained by the new regulator-only group.

But concern over this issue may be unwarranted, Kelly said, adding the task force’s regulator members are keen to maintain and build on the groundwork achieved to date. “It is therefore likely that any existing MOUs will be strength-ened, rather than negated. How to do this will be a decision for the new forum once established.”

Another GHTF meeting is expected this fall in Tokyo. — Virgil Dickson

EU Physicians Want U.S. FDA-Style System for Device Evaluation

The European Society of Cardiology (ESC) is calling for a single, coordinated European scheme to oversee the evalu-ation of medical devices — a system similar to the U.S. Food and Drug Administration’s (FDA).

“European patients are currently exposed to an unfair proportion of the risks associated with developing new devices,” Alan Fraser, an ESC board member says. “Stan-dards of testing of medical devices are less rigorous in Europe than the U.S.”

A coordinated system may be the most efficient way to harmonize processes between competent authorities so they apply uniform and higher standards, the ESC says. It could be organized as a medical device division of the European Medi-cines Agency, or as an entirely new body.

The group outlines its proposals in a May 14 academic article in the European Heart Journal based on a January policy meeting hosted by ESC and attended by FDA staff members. The ESC is hoping that EU officials will seriously consider the proposals, as revisions to the Medical Devices Directives are underway.

In addition to using a single European system for approv-als, the group suggests:

● Reorganizing notified bodies (NBs) as an integrated structure, with expertise concerning particular types of devices concentrated in single, or few, centers;

● Developing product standards for each category of medical device in Class II and Class III;

● Requiring expert professional advice; ● Developing the concept of conditional approval of a

medical device, pending further clinical evaluation; ● Undertaking, as a partnership between physicians,

companies and regulators, outcome studies after de-vice implantation;

● Defining limits to iterative changes; and ● Making manufacturers responsible for the clinical

evaluations of all Class II and Class III devices.

Currently, a manufacturer seeking approval to market a device in class IIa, IIb or III must undergo a conformity assessment procedure by one of the 74 NBs in Europe that deal with medical devices. Many of these NBs are indepen-dent commercial organizations.

“This process has given rise to suspicions that companies may go ‘forum shopping’ to select the NB that will conduct the least burdensome or the fastest review,” the paper says, adding, “No systematic audit of NBs has ever been published.”

Surrogate Endpoints

The current system also allows many devicemakers to use surrogate or functional endpoints in studies, even for completely new technologies. Manufacturers of pharmaceu-tical agents, by contrast, must establish an impact on clinical outcomes.

“It is essential that evidence of clinical efficacy, as well as safety and technical performance, is established before approval of any devices whose use may be associated with more than trivial risks,” the paper says.

One way to address this would be to develop catego-ries of devices in Class II and III, with medical experts rec-ommending specific standards for clinical performance and effectiveness, including requirements for follow-up studies.

Finally, the content of review submissions — minus con-fidential manufacturing details — should be disclosed to physicians so they understand the technical performance of the devices. They should also be able to review performance comparisons between devices within the same category, the paper says.

Recently, the FDA has expressed frustration about indus-try and regulators touting the EU system as better because devices get to the market there faster.

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“I’m not saying any one system is perfect by far, but the notion that Europe somehow has perfected the [regulatory] system has a lot of question marks right now,” Bram Zucker-man, director of an FDA division, has said.

About 11,000 companies market roughly 200,000 differ-ent devices in Europe. — Virgil Dickson

More Trade Groups Sign Agreement On Ethical Interactions With HCPs

Six additional medical technology associations are sign-ing on to a global ethical behavior agreement between their member companies and healthcare providers (HCPs).

The groups agreed to further their commitment to ethical collaborations by:

● Encouraging companies to adopt compliance pro-grams consistent with applicable industry codes;

● Providing guidance to the global industry on ethical business conduct relating to HCP interactions;

● Supporting education and compliance of member companies with laws, regulations and professional codes that impose stringent requirements regarding interactions with HCPs; and

● Working together to advance ethical collaborations through regular communication, joint policies, joint activities and other appropriate means.

In 2010, U.S. device association AdvaMed, European device association Eucomed and the European Diagnostic Manufacturers Association signed the first such agreement (IMDRM, May 2010).

Now, six additional associations have joined the effort, including the European Coordination Committee of the Radiological, Electromedical and Healthcare IT industry; the International Medical Device Manufacturers Association; MEDEC, the Canadian medical technology industry associa-tion; the Medical Technology Association of Australia; the Medical Technology Association of New Zealand and the South African Medical Device Industry Association.

Each association has its own codes of ethics, but the need to work together became apparent as device innovation increasingly extends beyond national and cultural borders, the organizations say.

“We hope that other associations will join us in our col-lective efforts to address compliance globally,” Eucomed Chief Executive John Wilkinson said.

The Global Statement on Ethical Interactions Between Medical Technology Companies and Healthcare Professionals is available at www.eucomed.org/uploads/_key_themes/Ethics/110519_global_compliance_statement2011.pdf. — Molly Cohen

APEC Endorses KL Principles for Device Sector Codes of Ethics

Medical devicemakers marketing products to the Asia-Pacific region should follow several principles for inter-actions with healthcare professionals (HCPs) recently endorsed by the Asia-Pacific Economic Cooperation (APEC) forum.

The forum endorsed the Kuala Lumpur Principles for Medical Device Sector Codes of Ethics (KL Principles) at its May meeting to help its 21 member economies address a lack of consistency, predictability and transparency in the laws and regulatory frameworks in the Asia-Pacific region.

Codes of ethics should include provisions dictating that:

● Collaborations between companies and HCPs should preserve independent decisionmaking;

● Consultations between HCPs and companies should support research and development to advance sci-ence, develop new technologies, improve existing products and services and enhance the quality and efficacy of care for patients;

● Company support for HCP education should preserve the independence of medical education and should not be used as a means of inappropriate inducement;

● Companies should provide training of HCPs on product-specific device deployment, use and application;

● Companies should not provide entertainment and recreation to HCPs as an inappropriate inducement;

● Company donations should support charitable orga-nizations that do not benefit HCPs; and

● Free products should not be used as a means of in-appropriate inducement, although companies may provide them for demonstration purposes.

The KL Principles also offer suggestions to encour-age adherence, advising devicemakers to appoint an execu-tive responsible for ensuring compliance with the industry code, adopt practical polices consistent with the code, provide effective training on company policies, institute appropri-ate internal monitoring and auditing mechanisms and create mechanisms for employees to raise concerns and communi-cate company policies to third-party intermediaries.

Good for SMEs

Ethical interactions provide a particular benefit for small- and medium-sized companies (SMEs) by freeing business environments from the high costs of corruption, enhancing the ability of companies, especially SMEs, to participate in global markets.

AdvaMed Executive Vice President Christopher White agrees these principles help to level the playing field for all device companies.

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“Too often … SMEs are shut out of growing markets due to corruption. A rigorous code of ethics allows companies of all sizes to compete fairly in markets and advance quality patient care,” White added.

The KL Principles are modeled after AdvaMed’s Code of Ethics, says White, who co-chaired the working group that developed the principles.

AdvaMed conducted a survey of the commonalities and differences between the individual country codes to harmonize them, following its basic ethics code (IMDRM, November 2010).

The KL Principles are available at www.apec.org/en/Press/News-Releases/2011/~/media/Files/Press/NewsRelease/2011/ The%20Kuala%20Lumpur%20Principles.ashx. — Molly Cohen

NICE Guides to Help Speed Up Product Listings in NHS

Device manufacturers can use new process and meth-ods guides from the National Institute of Health and Clinical Excellence (NICE) to get new medical technologies, or modi-fications to existing devices, used more quickly and consis-tently in the UK’s National Health Service (NHS).

NICE is hoping the new guides will prompt manufactur-ers to notify the institute about their products, allowing inno-vative devices to be used more quickly through the NHS.

The methods guide describes the principles and methods used to select and assess medical technologies, Carole Longson, director of the NICE Health Technology Evaluation Centre, said. “The documents will help the Medical Technologies Advisory Committee identify and select innovative medical technologies and route them through the appropriate NICE guidance program.”

The committee makes its decisions by weighing the ben-efits of adoption and applying selection and routing criteria, the guidance says. The committee will grant additional sig-nificance to certain criteria depending on the intended use of the device or technology, and the conditions it will treat.

The process guide describes how NICE selects topics and develops guidance on medical technologies, Longson said.

NICE’s Medical Technologies Evaluation Programme, established in 2009, has issued three final medical technology guidances: SeQuent Please balloon catheter for use in coronary artery surgery; CardioQ-ODM esophageal Doppler monitor to assess fluid balance during surgery; and the moorLDI2-BI, a laser Doppler blood flow imaging system to assess the severity of burns more accurately (IMDRM, August 2010).

The process guide is available at www.nice.org.uk/media/6D3/AF/MedTechProcessGuideFinalApril2011.pdf. The methods guide is available at www.nice.org.uk/media/67F/12/MedTechMethodsGuideFinal14Apr11.pdf. — Molly Cohen

Brazil Improves Device Assessment For National Health System

A new Brazilian law requires using protocols and guide-lines as part of enhanced assessment processes to increase access to medical devices through the country’s national health system, the Sistema Unico de Saude System (SUS).

Law 12.401, proposed by Brazil President Dilma Rous-seff, which aims to improve the inclusion of devices in the SUS, will be implemented within the next six months.

It will improve access to high-quality devices that adhere to criteria based on clinical protocols and therapeutic guide-lines created by health professionals from different SUS pro-visions, according to Latin America and Spain analyst for IHS Global Insight Ruben Gennero.

The law allows 180 days for manufacturers to demon-strate compliance with the new effectiveness, safety and cost-effectiveness criteria, with an additional 90 days for extension — an appropriate time to complete the safety and efficacy studies, Gennero said. It also includes a provision for consultation and public input.

Including Devices

The decision to include devices in the SUS will be gov-erned by the National Commission of Technology Incorpora-tion (Comissão Nacional de Incorporação de Tecnologias, Citec); coordinated by the Ministry of Health and integrated by represen-tatives from the Ministry, the National Agency of Supplementary Health (Agência Nacional de Saúde Suplementar, ANS) and the National Drug Regulator (Agência Nacional de Vigilância Sani-táría, Anvisa), as well as one member from the National Health Council and the Federal Council of Medicine, Gennero said.

But even though a reshaping of Citec’s capabilities and the inclusion of new members on the board will ensure transpar-ency, there is also a risk of bureaucracy under the new assess-ment paradigm, Gennero warns. “The real impact will be mea-sured when the law enters into force within the next six months.”

It introduces periodic assessments of medical technolo-gies offered by the SUS. The assessment criteria cover stan-dards for effectiveness, safety and cost as conditions for the inclusion of new products listed on the SUS, Gennero said.

This is the most recent change in a growing list of changes in Brazil that aim to improve medical device reg-ulation. In April, Brazil’s Attorney-General of the Union restricted Anvisa’s power to examine applications of intel-lectual property rights on medical products and reduced its role to weighing in on the scope of health risks on the product seeking patenting (IMDRM, April).

Last month, ANVISA began charging inspection fees for certificates of compliance with good manufacturing practice

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(GMP) and quality control every two years instead of annually to clear up confusion stemming from a 2009 law that called for annual quality system inspection fees while the GMP certifica-tion is renewable on a bi-annual basis (IMDRM, May).

The Ministry of Health’s announcement is available in Portuguese at portal.saude.gov.br/portal/aplicacoes/noticias/default.cfm?pg=dspDetalheNoticia&id_area=124&CO_NOT ICIA=12513. — Molly Cohen

Eucomed Outlines Key Points For eHealth Uptake

European device association Eucomed is pointing to seven steps necessary to overcome uptake barriers of eHealth — using information technology in medical applications.

As eHealth adoption expands, “medical devices will have to be developed in such a way that they can become part of this ‘sys-tem,’” Eucomed spokesman Thomas Lindemans told IMDRM.

“Some devices will need to be capable of communicating with patient record systems, others will have to be adapted to use outside of the hospital environment and yet others will depend on decisionmaking systems, which will determine whether this product, or another, is being prescribed,” he said.

Some manufacturers are already working with IT com-panies or developing software to support use of their products outside of the hospital. “Those companies will probably have a stronger market position in the future,” Lindemans said.

But for optimal adoption of eHealth, Eucomed is urging that eHealth programs, policies and legislation follow certain criteria, including:

● Ensuring patient, provider and healthcare system needs are the center of eHealth policies;

● Creating a framework for technical and semantic in-teroperability that enables standardization and harmoni-zation of disjointed national and local eHealth systems;

● Developing a value-based reimbursement and funding framework to compensate healthcare professionals for using eHealth technologies and remote services;

● Monitoring the legal certainty of eHealth products and services across member states;

● Establishing a leading European voice in presenting the value of eHealth for the future of EU healthcare systems;

● Emphasizing the appropriate uptake of new tech-nologies; and

● Allocating increasing funds to the health sector with priority given to eHealth technologies and projects.

According to a recent Eucomed position paper, eHealth is a growing industry in the EU. A 2010 study of eHealth com-missioned by the European Commission estimated the Euro-pean eHealth market at around $20 million in 2008 and it is projected to reach about $22 million by 2012.

Overall, Eucomed sees eHealth as an important trend for the device industry.

“It is only a matter of time before we drop the ‘e’ in ‘eHealth’ and view it as the benchmark,” Eucomed eHealth Work Group Chair Anna Lefevre Skjöldebrand, said.

Lindemans agrees, noting, “the data that eHealth solu-tions will produce are very important to medical technology manufacturers as they continuously develop new innovations and improve their products and services.”

Eucomed’s eHealth position paper is available at www.eucomed.org/uploads/ModuleXtender/Newsroom/70/110421_eucomed_ehealth_position_paper1.pdf. — Molly Cohen

Eucomed: Industry UDI Concerns Include Cost, Deviations in Use

As regulatory agencies worldwide prepare regulations on unique device identification (UDI), Eucomed is pointing out benefits of the technology, as well as industry concerns, such as cost to devicemakers and deviations in its use.

A UDI is a series of numeric or alphanumeric characters with a global coding standard to unambiguously identify a specific device. By 2018, all devices will be required to have a UDI.

UDIs make it easier to trace devices, allowing more effi-cient identification during recalls and more efficient busi-ness processes for manufacturers due to improved monitor-ing of usage and costs, according to Eucomed’s E-Business and Supply Chain Task Force (ETF), which released a general information sheet and a technical information sheet on UDI in early May.

However, industry has several concerns regarding the implementation of UDIs. For example, while UDIs will reduce healthcare costs in the long run, there will be an initial up-front expenditure for implementation.

“Manufacturers will face significant costs in altering pro-duction and labeling lines, and healthcare providers will need to be suitably equipped and their staff trained,” the ETF says.

The legislation will be directed only at manufacturers, so authorities will have to ensure healthcare systems are able to respond by increasing awareness and commitment among all stakeholders.

The group also highlights the need for industry to be prepared for UDI regulations and legislation, particularly since the European Commission is expected to include a UDI requirement in the upcoming recast of the Medical Devices Directives (IMDRM, April 2009). Additionally, the U.S. Food and Drug Administration is preparing UDI legislation, expected midyear (IMDRM, April). Meanwhile, the Global Harmonization Task Force (GHTF) is working to harmonize

INTERNATIONAL MEDICAL DEVICE REGULATORY MONITORJune 2011

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global requirements for UDI and a regulated UDI database (UDID) (IMDRM, December 2009).

Another concern for UDI implementation is deviations in use, which has already created issues, and on a larger scale, it could have a negative impact on supply chain efficiency, generating costs and risks, the ETF states. “It is essential that member state administrators are vigilant to ensure that this trend does not proliferate,” the group adds.

The ETF suggests a staged implementation of UDI, beginning with higher risk devices.

Moving forward, the group will focus on information sheets for UDID, which may be a greater concern for indus-try, it says.

But despite these concerns, there are many benefits to UDI in the areas of patient safety, supply chain efficiency, product traceability, electronic health records, anti-counterfeiting, reim-bursement, cross-border trading, authentication and eCommerce, ETF Chairman Mike Kreuzer has said.

Eucomed’s general UDI information sheet is available at www.eucomed.org/uploads/_key_themes/Regulatory/110405_general_information_sheet_UDI.pdf. The organization’s technical information sheet is available at www.eucomed.org/uploads/_key_themes/Regulatory/110405_technical_sheet_UDI.pdf. — Molly Cohen

EC Refers Spain to Court of Justice For Illegal Device VAT Rate

The European Commission (EC) is following through on its threat to refer Spain to the EU’s Court of Justice (EUCOJ) after the member state reduced its rate of value added tax (VAT) for medical equipment.

The referral follows the country’s “illegal application” of a reduced VAT rate for general medical equipment, which “may distort competition within the EU … within member states and between member states,” the EC said.

The VAT Directive (2006/112/EC) permits member states to use a reduced VAT rate for medical equipment for personal use, intended to treat disabilities. The rate is limited to prod-ucts listed in Annex III of the directive.

But Spain has been using a reduced VAT for medical equipment for general use “and so goes beyond the scope of what is allowed under the EU rules,” the EC says.

In November, the EC sent a reasoned opinion, the sec-ond step of an infringement proceeding, to Spain requesting the reduced VAT rates in question be withdrawn (IMDRM, December 2010).

However, Spanish authorities have not complied with the EC’s request. — Molly Cohen

New Conduct Code for NBs To Improve CE Mark Use

Several European notified bodies (NBs) have published a new code of conduct to improve CE certification for medical devices through quality harmonization, and to address weak points in the current system.

The code includes rules on:

● Implementation and monitoring of the code; ● Qualification and assignment of NB assessment

personnel; ● Minimum time for NB assessments; ● Sampling of class IIa and IIb technical files; ● Design dossier reviews; ● Rules for subcontracting; and ● Rules for certification decisions.

The new code was authored by BSI (UK), KEMA (Nether-lands), G-Med (France), TÜV Rheinland (Germany) and TÜV SÜD (Germany), and other NBs are invited to join. NBs that sign the code will have six months to implement the provisions.

The authors note several topics addressed in draft ver-sions were removed for the final version to ensure it was

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issued in a timely manner. They intend to add to the code in later stages after meeting with industry stakeholders. Topics left out include the IVD Directive, requirements for reviewing devices incorporating materials from humans, conformity assessments as defined by the Medical Devices Directive and requirements for “own brand labeling” manufacturers.

The NBs also plan to set up a Board of Compliance for the code before 2012, Erik Vollebregt, a lawyer specializing in EU medical device legal issues, says.

“I would imagine that they could easily adapt the Eucomed Code of Ethical Business Practice’s procedural framework, although there might be advantages of embed-ding the code in the national notified body accreditation decision one way or the other,” he adds.

Vollebregt also supports the inclusion of time limits for NB assessments. “This will make the audit durations a lot more predictable for companies, allowing for better plan-ning and subsequently smoother cooperation,” he says. The time limits are not set in stone, but it is “a good start.”

Lastly, Vollebregt commented on the subcontracting section of the code, saying it is no secret NBs do not have full expertise in-house at all times and resort to subcon-tracting review sections to third parties. The code indicates separate accreditation or designation of subcontractors is not necessary, but “this remains a weak spot that member states must watch,” he warns.

The code also may not fix medical device review prob-lems, Vollebregt notes, as it will be limited by how many and which NBs subscribe to the code, and how the Board of Compliance works in practice. “As Eucomed has shown, having a Board of Compliance is one thing, but getting com-panies to use it is another” (IMDRM, November 2009).— Molly Cohen

To view the text of the code of conduct, click here.

UK’s MHRA Defends NB, Device Regulatory System

The UK’s Medicines and Healthcare products Regula-tory Agency (MHRA) is defending its regulatory system in response to a review bashing medical device regulation in the UK.

The authors of the article, published in the British Medi-cal Journal (BMJ), say the MHRA’s surveillance of devices is “lax,” noting, “we found a substantial increase in the num-ber of field safety notices issued in the last five years by med-ical device manufacturers without concomitant increases in medical device alerts issued by the MHRA.”

The number of field safety notices increased by 1,220 percent, from 62 in 2006 to 757 in 2010, totaling 2,124 notices over that time span, they found.

Of those, 327 were high-risk Class III devices and more than half were cardiovascular system or musculoskeletal sys-tem devices. Medium-risk devices accounted for 1,527 field safety notices, and notices were also issued for 270 low-risk devices. Additionally, there were 447 medical-device alerts issued from 2006 to the end of 2010.

The increasing numbers represent “a substantial concern for overall safety and impact on healthcare costs in the UK,” the authors say.

But MHRA says it ensures the benefits of devices always outweigh the risks. “We monitor all adverse incident reports and take prompt action to address any safety or performance concerns,” it adds.

The review also notes it is “not unusual for us to find low-risk devices, (CE Class I devices) leading to potentially serious adverse events.” Such devices can include wheel-chairs and hoists.

However, lower-risk devices are not automatically subject to a clinical trial because it is often impractical and unneces-sary to test them in this way, and safety and performance can be assessed with laboratory tests, MHRA says.

Recommendations

The authors recommend better communication of recall risks, along with more clinical data and more frequent clini-cal investigations. Data from trials and investigations should be made public, particularly for the highest-risk devices.

Further, since the highest-risk devices are used for car-diovascular and musculoskeletal systems, “those areas should be prioritized for independent national registries of implant-able devices with publicly accountable data,” the authors say.

They also raise concerns with their inability to review clinical data provided to achieve a CE Mark, as the data are held by companies or notified bodies (NBs) and not a public body, such as the MHRA.

Approval of medical devices is coordinated by the MHRA, which certifies NBs to grant CE Mark certifications. The EU has 74 separate NBs, six of which are in the UK.

The MHRA monitors NBs to ensure they review manu-facturers’ postmarket surveillance activities and is consider-ing how best to ensure consistency in recognizing and audit-ing NBs across the member states.

The MHRA maintains that it “tackles its postmar-ket surveillance role very seriously and works with other

Conduct Code, from Page 6

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member states to ensure that only compliant devices are placed on the market.”

The BMJ article is available at bmjopen.bmj.com/content/early/2011/05/12/bmjopen-2011-000155.full.pdf. — Molly Cohen

Increase in UK Recalls Sparks Requests for Transparency

A substantial increase in the number of field safety notices issued by UK devicemakers in the last five years is leading to calls for greater transparency and more clinical data for devices.

The number of field safety notices, issued by a manufac-turer when a device is recalled for technical or clinical rea-sons, increased by 1,220 percent over the five-year period — from 62 in 2006 to 757 in 2010, according to a May 15 study by the Centre for Evidence-Based Medicine at the University of Oxford.

The researchers recommended a unified approval sys-tem for the EU, similar to a recent recommendation from the European Society of Cardiology.

They also pushed for stronger clinical data requirements, as a demonstration of efficacy is not part of the required pre-approval data for devices in the EU. Clinical data used for CE Marking may be either a review of relevant scientific litera-ture or results of a clinical study.

Unlike on the pharmaceutical side, no summaries are publicly available for the independent assessment of device data, the researchers say.

Centre Director Carl Heneghan says the Medicines and Healthcare products Regulatory Agency (MHRA) agrees. Last year, Susanne Ludgate, deputy director of the MHRA’s devices division, said she was “appalled at how many devices are brought to market with a lack of appropriate clinical data,” the researchers note. She criticized notified bodies for failing to adequately assess clinical data and challenge companies.

The MHRA plans to make changes to the way it handles adverse incident reports, including an “expanded and devel-oped system for identifying, analyzing and acting upon emerg-ing incident signals, patterns and trends,” the study says.

But MRHA defends its requirements. The agency ensures devices’ benefits always outweigh the risks, and monitors adverse incident reports to quickly address any safety or performance concerns, an agency spokeswoman told IMDRM.

The Center for Evidence-Based Medicine attempted to conduct a more UK-focused replica of a previous U.S. study that found devices cleared through the 510(k) pathway make

up more than two-thirds of Class I recalls. However, the Brit-ish researchers note they faced several roadblocks the origi-nal study had not encountered.

For example, attempts to obtain numbers of adverse events for specific devices were unsuccessful due to a confi-dentiality provision in the EU Medical Devices Directive that overrides UK freedom of information laws.

Additionally, the MHRA lacks accurate figures for the number of devices used, or how many have been replaced or discarded, the researchers say. “Obviously this information is most critical for high-risk Class III devices but unfortunately the [MHRA] does not hold a list of these devices.”

The researchers also raise concerns about their inability to access adequate clinical data or premarket approval data for recalled devices.

“We were stonewalled,” Heneghan says. About two per-cent of manufacturers were forthcoming in providing data to the researchers. In those cases, the data mainly consisted of literature reviews, which were not comparable with system-atic reviews.

The researchers are particularly concerned that they could not review any clinical data provided by devicemak-ers to achieve CE Marks, as the data are held by companies or notified bodies, rather than the MHRA. Therefore, they are not subject to the UK’s freedom of information law, a means by which researchers can access information.

“What seems unacceptable is a system of regulatory approval for devices that lacks even a basic level of transparency for independent evaluation,” the paper says. — Virgil Dickson

TGA Updates Its Risk-Management Approach for Regulating Devices

Australia’s Therapeutic Goods Administration (TGA) is updating its risk-management approach for medical products shortly after a report called on the agency to use a risk-based, streamlined approach in assessing device safety and efficacy.

Under the system, published May 6, devices are sorted into five different classes based on risk levels. The TGA assesses whether the design, manufacture and performance of a device conforms with essential principles of safety and per-formance, ensuring any risks are outweighed by the benefits. In vitro diagnostics (IVDs) are separated similarly into four classes based on risk.

TGA’s risk management approach focuses on identi-fying, analyzing, assessing, treating and monitoring risks associated with medicinal products. Different areas of the agency are responsible for each aspect of the risk manage-ment approach. The system is an update from the TGA’s 2004 risk-management approach.

INTERNATIONAL MEDICAL DEVICE REGULATORY MONITORJune 2011

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Device classification determines the conformity assess-ment procedures for manufacturers, and overseas manufactures of high-risk devices must hold a conformity assessment certifi-cate from the TGA before they can supply devices to Australia.

Once a device is approved, the TGA incorporates post-market activities to ensure the product continues to meet all regulatory and safety requirements. These activities include the manufacturer’s postmarket surveillance system, the TGA’s monitoring of market compliance and vigilance programs.

If new risks, like poor manufacturing processes or a breakdown in quality systems, are identified, the TGA has numerous enforcement options, including:

● Imposing new conditions on product registration; ● Applying additional conditions to the product’s

manufacture; ● Canceling the product’s registration so it cannot be

supplied in Australia; ● Suspending the product’s registration; ● Requiring mandatory recalls; ● Investigating alleged breaches to pursue prosecution;

and ● Issuing infringement notices.

The update comes shortly after a report from the Minis-ters of Finance and of Health and Ageing called for the TGA to use a risk-based, streamlined approach in making device safety and efficacy assessments (IMDRM, March). It also urged the TGA to develop protocols for sharing information with other health technology assessment (HTA) agencies by summer.

By next year, higher-risk devices should come under stiffer regulatory assessment by the TGA. Registries for high-risk implantable devices and procedures, with mechanisms to apply data from the registries to future HTAs, also are anticipated.

The risk-management approach is available at www.tga.gov.au/pdf/basics-regulation-risk-management.pdf. — Molly Cohen

U.S. FDA Seeks Comments on Regulations With Demonstrated Deficiencies

The U.S. Food and Drug Administration (FDA) is con-ducting a comprehensive review of its existing regulations and has requested comment on which of its rules may be out-dated, overly burdensome or otherwise ineffective.

The review comes in response to Executive Order 13563, which mandated each federal agency “periodically review its existing significant regulations to determine whether any such regulations should be modified, streamlined, expanded, or repealed so as to make the agency’s regulatory program more effective or less burdensome in achieving the regulatory objectives.”

The FDA’s first move is to seek comments on how the agency could revise its current review framework and which rules to prioritize for review. Comments are due June 27.

The agency has requested commenters focus on rules that have “demonstrated deficiencies” and have not been the subject of previously submitted arguments.

The FDA is particularly interested in “comments that identify impediments to innovation and suggestions for how they can be improved.”

Additionally, the agency asks commenters to address rules that “will achieve broad public impact, rather than an individual or corporate benefit,” and requests comments refer to specific regulations by their CFR citations.

Executive Order 13563, signed by President Barack Obama Jan. 18, is intended to build on and reaffirm Executive Order 12866, signed by President Bill Clinton in 1993.

Order 12866 required each federal agency to:

● Propose or adopt regulations only after making a determination about costs and benefits;

● Tailor regulations to impose minimal burdens on society; ● Select regulatory approaches that maximize benefits; ● Specify performance objectives rather than behavior

for regulated entities; and ● Identify and assess alternatives to direct regulation.

Additional information about submitting comments is available in the Federal Register publication notice at www.fdanews.com/ext/files/2011-10131_PI.pdf. — Wilson Peden

U.S. FDA Guidance Covers Delivery Devices for OTC Liquid Medicine

The U.S. Food and Drug Administration (FDA) recently issued a guidance document aimed at ensuring that labeling on dosage delivery devices, such as dosage cups, is consistent with labeling for the OTC liquid drug products with which they are used.

While most of these devices are marked with calibrated units, they can include measures not referred to in the drug product’s labeling, omit ones that are in the labeling or con-tain inconsistencies in language, such as “teaspoon” and “tsp,” the guidance says.

The agency said the frequency of incompatible labeling between OTC liquid medications and dosage delivery devices is on the rise and cited ongoing safety concerns about the potential for accidental overdoses, particularly in children.

Failure to provide compatible labeling could result in a drug product being considered misbranded or lacking ade-quate instructions, the guidance says.

INTERNATIONAL MEDICAL DEVICE REGULATORY MONITORJune 2011

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However, previous efforts to ensure conformity of drugs and dosage delivery devices, including a 1991 compliance notice sent to all drugmakers registered with the FDA and a January 2008 public health advisory concerning OTC pedi-atric cough and cold medications, have not improved compli-ance, the guidance says.

In addition, the guidance urges manufacturers to take steps to ensure dosage delivery devices are used only with their intended OTC product.

For instance, the manufacturer could include a statement on the product’s container or carton labeling stating that the delivery device is meant to be used with a particular product, or they could devise an integrated dosage device that secures it to the medication, the guidance says.

The guidance is available at www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guida nces/UCM188992.pdf. — Meg Bryant

U.S. FDA Guidance Gives Reprocessing Instructions for Reusable Devices

Manufacturers of reusable devices should consider human factors when developing labeling for these devices and validate their reprocessing instructions to make sure end users can follow them, a U.S. Food and Drug Administration (FDA) draft guidance says.

This validation testing, including observing participant behavior, will allow companies to assess adherence to the instructions and identify and understand problems that might occur, according to the May 2 draft guidance. Comments on the guidance, Docket No. FDA-2011-D-0293, are due by Aug. 1.

Reprocessing instructions for these devices should:

● Reflect the intended use of the device; ● Advise users to thoroughly clean the device; ● Indicate the appropriate microbicidal process for the

device; ● Be understandable; ● Include only devices and accessories that are legally

marketed; ● Be comprehensive; and ● Be technically feasible.

Where possible, devicemakers should also address issues such as the chamber size and chamber load differences that may exist between “industrial” and “healthcare facility” sterilizers.

Labeling should also include instructions for a reprocessing method that reflects the physical design of the device and the soil-ing and contamination to which it is subject during clinical use.

Reprocessing instructions should be consistent with current infection control practice, the guidance notes. The

microbicidal process recommended should be sterilization, or high-, intermediate- or low-level disinfection, depending on the intended use of the device.

If a device consists of more than one removable part, the labeling should include step-by-step instructions for disas-sembly and reassembly and state the equipment required.

The guidance updates guidance from 1996 on labeling for these devices.

The document is part of a multi-pronged approach launched by the FDA in late April to help reduce the risk of patient exposure to improperly reprocessed devices.

An agency review of adverse events for endoscopes found 80 reports of inadequate reprocessing and 28 reports of infection that may have occurred from inadequate reprocess-ing between Jan. 1, 2007 and May 11, 2010.

In addition to the guidance, the FDA is working with standards-setting groups to develop standards and technical information reports that update processes, materials, test methods and acceptance criteria for cleaning reusable medical devices.

The agency plans to hold a two-day public workshop on the issue June 8 and 9.

The guidance can be found at www.fdanews.com/ext/files/UCM253010.pdf. — Virgil Dickson

U.S. FDA Draft Guidance Outlines Study Requirements for STD IVD Tests

Devicemakers conducting performance studies to estab-lish the analytical and clinical performance of in vitro diag-nostics for chlamydia or gonorrhea should run appropriate external controls daily for the duration of the analytical and clinical studies, draft guidance from the U.S. Food and Drug Administration (FDA) says.

Appropriate external controls can include strains of C. tra-chomatis commonly found in the U.S. An N. gonorrhea refer-ence strain, such as ATCC 49226, is an appropriate external control for testing of gonorrhea diagnostics, according to the May 11 guidance. Comments on the draft are due by Aug. 9.

Devicemakers establishing analytical sensitivity for chla-mydia strains should determine the limit of detection (LoD) using limiting dilutions of regrown and retitered C. trachomatis stocks.

Performance studies for LoD should include serial dilu-tions of at least two strains representative of types commonly found in the U.S., using at least 20 measurements for each dilution, the agency says.

These studies should include sources of variability at differ-ent days — at least three to five days — and different runs, with at least two runs per day and at least two replicates per run.

INTERNATIONAL MEDICAL DEVICE REGULATORY MONITORJune 2011

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Devicemakers establishing analytical sensitivity for gon-orrhea strains should determine LoD using limiting dilutions of regrown and retitered stocks of an N. gonorrhoea reference strain such as ATCC 49226. The study should include serial dilutions of two reference strains using at least 20 measure-ments for each dilution.

Sponsors also need to conduct prospective clinical stud-ies to determine the test’s performance for all the speci-men types claimed in the labeling. The assay’s performance should be judged versus the patient’s infected status, which is determined using two FDA-cleared nucleic acid amplification test assays detecting different target sequences.

A copy of the guidance, Docket No. FDA-2011-D-0272, can be found at www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm254813.htm#5.— Virgil Dickson

U.S. FDA Seeks Postapproval Hip Implant Studies

The U.S. Food and Drug Administration (FDA) is ask-ing 21 devicemakers to conduct postapproval studies for their metal-on-metal (MoM) hip implants after reports of high ion concentrations of cobalt and chromium in the blood of patients using the devices.

The elevated levels of the elements may be related to increased rates of adverse events, according to a recent letter from the FDA’s Center for Devices and Radiological Health (CDRH) to the devicemakers obtained by IMDRM.

The center is asking devicemakers to discuss the adverse events observed in patients with MoM total hip replacement (THR) and the patient population’s average blood chromium level. These events can include increased pain, adverse local tissue reactions or revision.

Manufacturers have 30 days to submit a plan to con-duct the surveillance. The FDA will then determine whether each plan will result in useful data that can reveal unforeseen adverse events or other information necessary to protect the public health, Ron Yustein, associate director for the Office of Surveillance and Biometrics at CDRH, said May 9 at an FDA workshop for the International Consortium of Orthopaedic Registries.

The center also seeks data on the demographics or patient selection criteria associated with higher metal ion concentra-tions, and information on the causes of device failure based on analysis of explanted and retrieved devices.

Among the agency recommendations are:

● A cross-sectional study design that captures patients with or without revision to the original MoM THR at periods between initial implant and eight years later;

● Evaluation of cardiac, neurological and immunosup-pressive events; and

● Failure analysis study within the clinical study pro-tocol to evaluate explants.

Both Depuy and Zimmer have expressed confusion over the mandate. The companies told IMDRM they are seeking further clarification from the FDA on how to best meet and understand the scope of the agency’s request.

Other devicemakers are confident their products can stand up to the additional scrutiny. For example, Biomet has already collected clinical data on approximately 23,000 hips treated with its M2a all-metal implants, including data from U.K., Australian, Swedish and Finnish national joint reg-istries, pre- and postmarket studies and published clinical results, spokeswoman Sue Alexander told IMDRM.

At an average follow-up of 2.6 years, 98 percent of the 11,654 implants for which it has data on length of time since implantation are in place and functioning, she said. These results are comparable to those of metal-on-polyethylene hip replacements as reported in the Australian and New Zealand national joint registries, she added.

The mandate comes about a month after a Senate com-mittee promised to keep a close eye on the FDA’s device review process in the coming months. The hearing was called, in part, due to the recalled MoM DePuy ASR XL ace-tabular and hip resurfacing systems brought to the market through the 510(k) process despite being Class III devices.

Prior to the Senate hearing, the FDA had already launched an internal investigation into MoM hip implants after the National Joint Registry of England and Wales released data that showed high revision rates for the Depuy implants. After the study was released, the FDA said it was still unclear how widespread the issues with the devices were.

“There are several differences between the UK and U.S. regulatory systems, and some of the UK data may not be directly applicable to the experience in the U.S.,” the agency said at the time.

A copy of the letter can be found at www.fdanews.com/ext/files/MoM522Order-final-05052011-redacted.pdf.— Virgil Dickson

Dues Could Fund Network for U.S. Postmarket Surveillance System

The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) is moving for-ward on the Medical Device Epidemiology Network (MDEpi-Net) and considering a preliminary infrastructure for the ini-tiative, which would link information from device registries and databases.

INTERNATIONAL MEDICAL DEVICE REGULATORY MONITORJune 2011

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The partnership could be funded partially by charging membership dues, Steve Phurrough, chief operating officer for the Center for Medical Technology Policy (CMTP) sug-gested at an April 25 FDA workshop. In early April, the FDA hired CMTP to help develop MDEpiNet.

This idea met with some resistance, as too little is known about how the partnership will work.

“I’m hesitant about dues without them being tied on something tangible,” David Naftel, a cardiac surgery profes-sor at the University of Alabama at Birmingham, said.

The MDEpiNet initiative, launched last year, would join FDA experts with academia and others to address evidence gaps in device safety information, and develop new approaches for studies to improve understanding of device safety and effectiveness throughout products’ life cycles.

Although the manner in which industry and others will contribute funding is uncertain, the FDA plans to par-tially fund the initiative, Danica Marinac-Dabic, director of CDRH’s Division of Epidemiology, said.

The agency is still considering how much funding it can provide, due to ongoing uncertainties about the federal bud-get process.

A complete business plan is due in September.

Phurrough also suggested an advisory panel of represen-tatives from all members, including FDA, industry, other fed-eral agencies and academia, could govern the partnership.

The panel would oversee the MDEpiNet Operations Commit-tee (M-DOC), which would be responsible for day-to-day man-agement of the partnership, Phurrough told workshop attendees.

The M-DOC would also establish research priorities for the partnership and manage three subcommittees — project, budget and dissemination.

The project subcommittee would be responsible for developing a research program and research priorities. It would create proposal requests for each topic, along with cri-teria for selection.

The budget subcommittee would secure funding for MDEpiNet and specific projects.

The dissemination subcommittee would plan meetings, con-ferences and workshops; develop and manage the publication process; and develop translation tools for various audiences.

Moving forward, the FDA is waiting for a more granular proposal for the governance of MDEpiNet.

“I think we still have a ways to go here on the pathway,” Wendy Sanhai, senior scientific adviser in FDA’s Office of the Commissioner, said. — Virgil Dickson

It’s your job to know the FDA’s medical device regulations inside out. But device regulations can be amoving target. Here’s help keeping them in your sights. In its first revision in three years, the 2011Guide to Medical Device Regulations is the most comprehensive, authoritative, up-to-the-minuteguide to device regulations available anywhere.

It includes full texts of every device-related regulation currently in force, plus Executive Summariesand Analyses outlining their impact on companies like yours. That’s only the beginning. The Guidealso features:

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U.S. FDA May Double User Fees Under Reauthorized MDUFMA

Devicemakers could end up paying as much as $600 million in user fees over five years under the U.S.’s Medical Device User Fee and Modernization Act (MDUFMA) III — twice as much as they paid under the last reauthorization.

Citing concerns about a possible drop in federal funding, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has said it will need to double the amount of fees it collects to keep the review program run-ning as is, Pat Schrader, vice president of corporate regulatory affairs for Medtronic said at the Association of Medical Diagnos-tics Manufacturers (AMDM) annual meeting April 29.

It is unclear if CDRH will be able to achieve such an increase, considering industry concerns the current review process is taking longer and becoming unpredictable — to the point where venture capitalists have become less enthusi-astic about funding device projects.

“Needless to say, doubling what we pay to get the same performance didn’t sit well with industry,” Schrader said, recounting discussions at a closed-door reauthorization meet-ing held with the FDA April 13. The FDA published notes from the meeting April 28 but did not discuss the user fee increase.

According to the minutes, the FDA described three dif-ferent scenarios for budget authority (BA) and appropriations for the device review process:

● A 4 percent annual increase in BA; ● No increase in BA; and ● A 4 percent annual reduction in BA.

With a 4 percent annual increase, the FDA estimates it could maintain its current full-time equivalent (FTE) staff levels. In the flat appropriations scenario, a potential fund-ing shortfall of $9.4 million in 2013 could mean a loss of 33 FTE; by 2017, the potential shortfall could rise to $51 million, resulting in a cumulative loss of 153 FTE.

In the 4 percent reduction scenario, the funding shortfall could be $18.8 million in 2013, resulting in a loss of 66 FTE;

by 2017, the shortfall could be $94.5 million, resulting in a cumulative loss of 284 FTE.

If staff reductions occur, devicemakers would see signifi-cant declines in review performance, the FDA said.

About two weeks before the April 13 meeting, CDRH Director Jeffrey Shuren said the center may look to user fees to help make up for any loss in federal funding, though he was not forthcoming about how much more the office would lean on industry.

Industry has not yet determined what percent of the review process would be funded by devicemakers should the new fee proposal pass Congress. Currently, user fees cover about 23 percent of the review process for device submis-sions, compared with 60 percent for drug submissions.

But device user fees are already too high, as the FDA and industry had reached an informal agreement under MDUFMA I that devicemakers would not pay more than 15 percent of review costs with user fees, Schrader said.

She noted that CDRH also hopes to continue using “FDA days” to measure review timelines, rather than calendar days, which are favored by industry. The MDUFMA III proposal submitted to industry last month sought to retain the cur-rent metric of reviewing 90 percent of 510(k)s within 90 FDA days, and 98 percent within 150 FDA days.

“FDA days” differ from calendar days because the review clock stops when the agency asks additional ques-tions of sponsors about a submission. Sometimes it can take months for a company to respond.

Maintaining the “FDA days” standard is important to the agency as it is concerned about being evaluated on issues out-side of its control, Schrader said.

However, industry is growing increasingly irritated with the FDA claims of meeting most review goals when it is tak-ing, on average, 272 calendar days to review 510(k) sub-missions, up from 90 calendar days when MDUFMA first started, Schrader said. Industry will continue to push for the calendar day metric, she added. — Virgil Dickson

Reporters: Virgil Dickson, Kevin O’Rourke, David Pittman, Sarah Karlin

President: Cynthia Carter; Editorial Director: Pamela Taulbee; Executive Editor: April Hollis

Copyright © 2011 by Washington Business Information Inc. All rights reserved. International Medical Device Regulatory Monitor (ISSN 1079-6940) is published monthly, 12 issues, for $749. Photocopying or reproducing in any form, including electronic or facsimile transmission, scanning or electronic storage is a violation of federal copyright law and is strictly prohibited without the publisher’s express written permis-sion. Subscribers registered with the Copyright Clearance Center (CCC) may reproduce articles for internal use only. For more information, contact CCC at www.copyright.com or call (978) 750-8400. For site licenses for multiple users or to purchase multiple copies, contact Andrew McSherry at (703) 538-7642.

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EU and FDA regulators continue to apply different sets of requirements for medical device mar-ket approval, despite longstanding attempts at harmonization.

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