Devicemakers quiz FDA on

plan to permit third-party

audits........................Page 2

ARJ gets warning letter for

not having several written

procedures................Page 2

Boston Scientific resolves

warning but faces investi-

gations......................Page 4

FDA warns diagnostics

company for validation,

testing issues ............Page 4

483 Insider ..............Page 5

Guidance, standards ex-

pected from FDA nanotech

initiative ...................Page 7

AdvaMed: Universal spec-

trum needed for wireless

devices .....................Page 9

Devicemakers: Changes

necessary in draft infusion

pump guidance.......Page 11

New Zealand devicemaker

placed on import alert for

GMP violations ......Page 11

Issue No. 368

September 2010FDA Asks Devicemakers to Do More

To Help With Supply Oversight

The FDA is trying to stretch its enforcement reach over foreign

device suppliers, potentially through consent decrees, and is asking

manufacturers to take bigger steps as well to tighten the supply chain.

Currently, the agency only has authority to establish import

alerts for foreign companies with GMP violations, but it is looking

at other options, Carmelo Rosa, an FDA compliance officer, told

GMP last month at the second annual FDAnews Supplier Quality

Management Congress.

For example, the agency is not ruling out seeking a company’s

compliance through a consent decree that affects both its domestic

and foreign divisions, he said.

(See Oversight, Page 8)

FDA to Request Proposals Soon

For UDI Database Development

After years of promises, the FDA says it plans to publish, within

the next few months, a request for proposals (RFP) to begin the de-

velopment and building of a unique device identifier (UDI) database.

The agency hopes the database will be completed in the next

12 months, Jay Crowley, senior adviser for patient safety at CDRH,

told GMP.

The implementation of the database is predicated on the publi-

cation of a final UDI rule, he added. But the agency has yet to pub-

lish even a proposed rule.

Crowley has said the agency hoped to have a proposed rule out

by this past spring (GMP, November 2009). Then the release of the

proposed rule was pushed to this summer with a final rule to come

out in April 2011 (GMP, April).

IINNSSIIDDEE TTHHIISS IISSSSUUEE

(See UDI, Page 12)

Devicemakers Quiz FDA on Plan

To Permit Third-Party Audits

Devicemakers want more clarity on third-

party audits by regulatory agencies in other coun-

tries, especially when it comes to possible en-

forcement actions.

In one of 28 comments on the FDA’s draft

guidance on the program, Cardinal Health asks

whether the FDA could take enforcement action

against a company as a result of such an audit.

The final guidance needs to address the

FDA’s authority over a manufacturer’s responses

to the third-party auditing agency, Cardinal

Health says, as well as the steps the FDA would

take if it does not agree with the company’s re-

sponse and proposed corrective actions.

The draft, released in May, covers third-party

audits based on the International Organization for

Standardization’s 13485:2003 and conducted by

one of the other founding members of the Global

Harmonization Task Force — Australia, Canada,

the EU and Japan (GMP, June).

The guidance needs to clarify how the FDA

will inform devicemakers that they have been ac-

cepted or rejected for the program, Johnson &

Johnson’s Ortho Clinical Diagnostics says.

Improving Participation

Another issue is participation. More needs to

be done to encourage devicemakers to use the

third-party program, AdvaMed says. It suggests

exempting participating companies from FDA in-

spections for up to three years — so long as they

have a good compliance history. The draft pro-

poses a one-year exemption.

If a participating devicemaker decides to opt

out of the program, it should not be penalized,

AdvaMed says. However, companies should be

required to notify the FDA when they leave the

program and explain their reasons, the trade

group adds, noting that such information could

lead to program improvements.

The FDA also could encourage participation

by regularly providing general metrics that allow

manufacturers to evaluate how the program is

functioning, AdvaMed says.

The Japan Federation of Medical Devices

Associations recommends some changes to the

program based on differences among the regula-

tory agencies. For instance, in Japan, regulatory

audit reports are issued in Japanese, but they

would have to be translated into English before

being submitted to the FDA.

The draft guidance requires that the reports

be submitted within 60 days from the last day of

the audit. Getting the translation in that time

frame may be difficult, the Japanese trade group

says. — Virgil Dickson

Page 2 THE GMP LETTER September 2010

ARJ Warned for Not Having

Several Written Procedures

ARJ Medical has received a warning letter

citing it for lack of written procedures for its uri-

nalysis reagent strips.

An FDA investigator noted that a company

official told him during a March inspection that

ARJ had no written medical device reporting pro-

cedure, according to the July 16 warning letter

posted last month.

The Oldsmar, Fla., company also had no writ-

ten procedures for corrective and preventive ac-

tion, complaint handling, specification confor-

mance of purchased products and services, and de-

sign control, including labeling requirements. In

addition, ARJ had not developed a quality policy.

ARJ’s responses to the observations in the

Form 483 are inadequate because they do not ful-

ly address the requirements, the FDA says. The

company also failed to submit a specific plan or

evidence of immediate corrections and systemic

corrective actions.

ARJ was further cited for marketing unap-

proved pregnancy and drug screening tests on its

website. It has since pulled the site off the internet.

The company did not respond to a request

for comment. The letter is available at www.fda.

gov/ICECI/EnforcementActions/WarningLetters/

ucm219614.htm. — Mari Serebrov

September 2010 THE GMP LETTER Page 3

Page 4 THE GMP LETTER September 2010

Boston Scientific Resolves Letter

But Faces Federal Investigations

The news Boston Scientific has been waiting

for — that it has resolved all the observations noted

in a 2006 corporate warning letter that cited serious

deficiencies at three of its facilities — was tem-

pered last month by looming federal investigations.

The company was informally told in January

that it had adequately addressed the issues in the

FDA warning letter, but the company had to wait

seven months for the agency’s official blessing,

according to an SEC filing.

The warning letter cited the company for

“inadequate corporate-wide corrective action

plans” as evidenced by continuing serious defi-

ciencies identified at three plants that produced

drug-eluting stents and a needle electrode (GMP,

February 2006). The corporate warning was sent

after the company failed to adequately respond to

three warning letters issued in 2005.

Federal Investigation

Last month’s positive news capped several

days of negative publicity that followed an earlier

filing with the SEC that revealed Boston Scientif-

ic was being investigated by the U.S. attorney in

Massachusetts.

The U.S. attorney wants information about

Boston Scientific’s March 15 ship-hold and recalls

of its implantable cardioverter defibrillators and car-

diac resynchronization therapy defibrillator systems

(GMP, April). The U.S. attorney also is subpoe-

naing documents relating to a market development

sales organization that operated within the compa-

ny’s cardiac rhythm management business.

The company is cooperating with the inves-

tigation and another by the Justice Department

regarding reimbursement, but spokesman Paul

Donovan declined to comment further.

The month-long shipment hold, stemming

from unapproved manufacturing changes, is expect-

ed to cost Boston Scientific $300 million this year.

The company also is facing a $91,000 fine

from the Federal Aviation Administration (FAA)

for allegedly violating policies on transporting

hazardous material. The agency recounted an

Oct. 23, 2009, incident in which DHL workers in

Cincinnati discovered a leaking box containing

“medical-grade silicon fluid, a flammable liquid.”

The undeclared package was being flown from

Alajuela, Costa Rica, to Boston Scientific’s head-

quarters, the FAA says. — Virgil Dickson

FDA Warns Diagnostics Company

For Validation, Testing Issues

MP Biomedicals’ diagnostics division re-

ceived a warning letter citing a number of valida-

tion issues involving its in vitro diagnostics (IVDs).

The company’s Solon, Ohio, facility averaged

out-of-specification (OOS) values or allowed the re-

moval of one OOS value during finished device

testing, according to an Aug. 2 warning letter posted

last month. As a result, the test records for 17 of 30

phenylalanine kits reviewed by an FDA inspector

had one of three values out of specification.

The company did not investigate the cause

of the OOS results or provide a written justifica-

tion based on a statistical rationale for accepting

them, the letter says (GMP, August).

The inspector also observed that when the

facility established values for its calibrators, it

routinely removed data points without document-

ing and justifying the rationale for the removal.

Other problems cited in the letter include

failure to:

● Validate the foil bag sealing process used to

protect components of IVD kits from moisture;

● Validate the mixing, filling, plate coating,

tube coating and cleaning processes used to

manufacture components of the kits; and

● Conduct stability testing on IVD kits and their

components to ensure they remained stable at

the temperatures and in accordance with the

expiration dates indicated on the device labels.

MP said it is resolving all the issues raised in

the warning letter. The letter is available at www.

fda.gov/ICECI/EnforcementActions/WarningLet

ters/ucm221116.htm. — Mari Serebrov

September 2010 THE GMP LETTER Page 5

Quasar 483 Notes a Lack

Of Vetting Procedures

Quasar Bio-Tech did not establish and imple-

ment procedures for the manufacture and in-process

control of electronic devices made by its contract

manufacturer, according to a recent Form 483.

The Sarasota, Fla., company also had not

conducted site audits or maintained a contractual

agreement with the contractor to determine if it

was processing Quasar’s electronic devices ac-

cording to cGMPs, the May 11 form says.

Quasar hired a consultant to assist with es-

tablishing and implementing a quality system and

conducting internal audits. But in hiring the con-

sultant, the company failed to comply with the

established supplier procedures and complete a

supplier evaluation for nearly a year.

Quasar maintains no written procedures for

documenting device history records, identifying

and documenting its rework process for returned

devices, or reusing a returned/refurbished device,

the form says. Returned devices are reportedly

retested, cleaned, refurbished, if necessary, and

distributed as replacement units.

The company did not respond to a request for

comment by press time. The Form 483 is available

at www.fdanews.com/ext/files/Quasar.pdf.

Insight Gets 483 Citing

Complaint Handling

Insight Instruments received a Form 483 with

several references to its handling of complaints.

For example, the Stuart, Fla.-based company

received a complaint that a surgeon had difficulty

removing a mini-light from a patient’s eye. Upon

removal, the surgeon found the device was de-

formed. Insight determined the device could de-

form due to overheating, the May 3 form says.

The company received a similar complaint

involving the mini-light several months later. In

this instance, the surgeon had to enlarge the pa-

tient’s sclerotomy to remove the device and make

an additional suture. Insight failed to report it as a

medical device reportable event.

The company also failed to initiate corrective

action for its other model of the device or docu-

ment an adequate reason for not taking action.

The FDA investigator observed that Insight

did not require assurance from the contract manu-

facturer of its Cornea Coat that tests are conduct-

ed to detect impurities or that the filtration

process is properly validated, the form says.

The company did not respond to a request

for comment by press time. The 483 is available

at www.fdanews.com/ext/files/Insight.pdf.

Eminent 483 Notes Validation,

Lack of Documented Procedures

Eminent Spine received a Form 483 after the

FDA found its cleaning instructions for interverte-

bral body fusion systems were not validated to

show the procedure is capable of removing contam-

inants, such as body fluids, from the instruments.

A March inspection of the Georgetown,

Texas, company also found it had not established

procedures for the acceptance activities for its

systems after they had been used in surgery.

The investigators examined a Sidewinder in-

tervertebral body fusion system that had been re-

turned after surgery, inspected and released for

distribution, according to the March 9 form. They

observed a reddish-brown substance on an inner

thread and on the thread near the head of the de-

vice that is handled by the surgeon.

Eminent also did not have a procedure or

quality agreement to define supplier responsibili-

ties and had not conducted a formal, documented

internal audit, the form says. It did not have a doc-

umented quality policy or established corrective

and preventive action procedure as of March 3.

The company did not respond to a request

for comment by press time. The Form 483 is

available at www.fdanews.com/ext/files/Emi

nent.pdf.

FFOORRMM 448833 IINNSSIIDDEERR

Page 6 THE GMP LETTER September 2010

September 2010 THE GMP LETTER Page 7

Guidance, Standards Expected

From FDA Nanotech Initiative

Devicemakers will likely see new guidance

and consensus standards on nanotechnologies in

the near future as the FDA moves forward on its

research and regulation of the technology.

The agency also could produce new test

methods, publications and presentations as part of

its 2011 Nanotechnology Regulatory Science Ini-

tiative, Subhas Malghan, deputy director for pro-

gram policy and evaluation at CDRH, said at a

meeting of the FDA’s Science Board last month.

Nanotechnology refers to processes that in-

volve tiny materials –– as small as 1/100,000th of

a human hair –– used in the manufacture of de-

vices, drugs and cosmetics. Nanomaterials tend to

have significant differences compared with their

larger counterparts, such as increased structural

integrity, amplified chemical and biological activ-

ity, and altered magnetic properties and electrical

or optical activity, giving them the potential for

use in a variety of products.

Task Force: Guidance Needed

The FDA’s Nanotechnology Task Force is-

sued a report in 2007 recommending the agency

develop guidances to inform industry on how it

plans to regulate products that use nanotechnolo-

gy materials, with a focus on safety. Since then,

the EPA and other groups have called on the FDA

to provide industry guidance on new nano prod-

ucts and to collect information on safety testing,

forthcoming products and adverse events (GMP,

March 2009).

In the next few years, the FDA plans to en-

hance its external and cross-center activities and sup-

port external research programs related to nanotech-

nologies, Malghan said. It also will equip core labo-

ratory facilities to build its capacity to assess nan-

otechnology products, and it will work to develop

criteria for the review of such products.

Some products will have enough similar char-

acteristics that the FDA can treat them as a category,

with the result being no difference in the questions

the agency would ask during reviews. But because

of the range of nanotechnologies and what can be

done with them, there may be additional questions

the agency must address in its review of some prod-

ucts, Carlos Pena, senior science policy adviser in

the FDA’s Office of the Commissioner, noted.

One of the agency’s priorities is to define the

physical and chemical characteristics of nanomate-

rials that affect potency and impact safety. The

FDA also hopes to learn about the interaction of

nanomaterials with biological processes in tissues

and fluids, as well as safety issues such as toxico-

kinetics via in vitro and in vivo toxicity tests.

During last month’s meeting, the Science

Board advised the FDA on defining nanotechnol-

ogy, with some members encouraging the agency

to take the international lead in that area.

Staff Training

The agency also plans to focus on training, it

told board members. Ongoing FDA activities in

staff training and professional development in-

clude product-specific expert presentations,

workshops and center-specific activities.

The agency may have great plans, but it

“just does not have the resources,” Science Board

Chairwoman Barbara McNeil, a radiology profes-

sor at Harvard Medical School, pointed out.

The agency’s fiscal 2011 budget request in-

cludes $7.3 million for emerging science, including

nanotechnology, Jesse Goodman, FDA’s chief sci-

entist and deputy commissioner for science and

public health, told the board. But Goodman said he

shared panelists’ concerns about limited resources

and the fact that product development “may be out-

pacing where we’re at with the predictive sciences.”

Board member Alan Russell, director of the

McGowan Institute for Regenerative Medicine at

the University of Pittsburgh, suggested the

agency work harder to focus its resources. For

example, it should “invest hugely” in trying to

understand the inadequacy of current testing

practices for determining the safety and efficacy

of nano-sized molecules, he said. — April Hollis

Page 8 THE GMP LETTER September 2010

Kim Trautman, medical device quality sys-

tem expert at CDRH, told attendees to focus on

planning prior to supplier approval. Planning

should include a description of what must be ob-

tained from a potential supplier.

Manufacturers should identify the technical and

process information, potential suppliers, risks, con-

trols, and the type and extent of control necessary to

manage those risks. Evaluation and acceptance crite-

ria should be defined clearly prior to evaluation.

Planning deficiencies are the “easiest place

for the FDA to write up problems,” Trautman

said. “This is the No. 1 area I would say you are

likely to have a 483 observation … if you don’t

do this type of planning process.”

Validate Supplier Information

Companies also must validate information

from suppliers, she said. If a supplier provides evi-

dence of process validation, “there has to be some

sort of documentation that [the manufacturer] re-

viewed that, approved that and subsumed it,” or in-

vestigators will cite the manufacturer, she added.

FDA investigators will look for a direct link

from a manufacturer’s statistical sampling plans

back to supplier controls, design controls and risk

management activity.

“If we see that 15 incoming components are

being accepted under the same sampling plan,

under the same [acceptable quality level], that is

a huge red flag … especially if they are all com-

ing from different suppliers,” Trautman said.

Manufacturers may have to take special con-

siderations with suppliers in specific regions. In

the Asia/Pacific region, the agency has noted

problems with shadow companies, where the fa-

cility listed as the manufacturer is not actually

manufacturing the product.

“Sometimes we have to go two to three sites

beyond what was supposed to be the manufacturer,”

Trautman said. “You have to really challenge your

first-tier suppliers about what they are subcontract-

ing out. … The more they are subcontracting out,

the more controls you are going to have to place

on them.”

Another area to watch is inadequate labora-

tory controls. The agency has seen a significant

increase this year in foreign GMP citations for in-

adequate laboratory controls, Rosa said. In partic-

ular, 23 percent of citations for Chinese compa-

nies were for this issue, along with 9 percent of

citations to Indian companies.

Other common citations for foreign companies

were for standard operating procedures, quality as-

surance and deficiencies in reports and records.

Devicemakers should be going to suppliers

and making sure their products are being manu-

factured in accordance with specifications.

Rosa also advised taking a good translator.

— April Hollis

Oversight, from Page 1

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AdvaMed: Universal Spectrum

Needed for Wireless Devices

To keep up with the reality of wireless med-

ical technology, the FDA and Federal Communi-

cations Commission (FCC) must make more ef-

fort to globalize medical telemetry bands, evalu-

ate threats to patient safety and clarify current

regulations.

Worldwide wireless medical telemetry alloca-

tions are the exception, not the rule, AdvaMed says

in a comment posted after a recent meeting on reg-

ulation of wireless devices. “This lack of global-

ization has consequences,” it adds, noting that

without international bands, manufacturers must

develop different devices for use in different coun-

tries. This adds to the cost of product development.

The group cites the FCC’s development last

year of the MedRadio Service as an example of

how U.S. regulatory agencies can foster interna-

tional standards. The service allocates specific

spectrum, harmonized with EU standards and other

international regulations, for implanted and body-

worn medical devices. But the spectrum allocation

is not yet universal, according to AdvaMed’s com-

ment, which was one of 37 submitted by the dead-

line last month.

FDA-FCC Partnership

The FDA and FCC recently signed a memo-

randum of understanding to improve the efficien-

cy of regulatory processes for devices using

broadband and wireless technology.

As part of this goal, AdvaMed advises the

agencies to evaluate all new communication tech-

nology for possible negative effects on medical de-

vices, particularly those that are implanted or worn.

The FDA and FCC also should urge technol-

ogy developers and those creating standards for

new technology to consider how communication

devices may interact with medical devices. Using

standards when designing medical devices and

considering the likely operating environment can

reduce the risk of interference, AdvaMed says.

But currently, medical device electromag-

netic compatibility standards evolve to reflect

new emitters that may be sources of interference

only after the emitters have become known and

characterized fully.

Therefore, it is important to quantify and

consider electromagnetic interference to med-

ical devices when new international communi-

cations standards are being developed, accord-

ing to AdvaMed.

In its comment on the issues presented at the

July meeting, the mHealth Regulatory Coalition

(MRC) focuses on the need for regulatory clarity.

Connectivity of medical devices to mobile and

wireless networks is one of the most significant

challenges the FDA has faced, the group says.

However, the coalition is concerned that if the

agency is too vigorous in its oversight, it could

create significant barriers to innovation.

Understanding Device Uses

One way to avoid unnecessary oversight is

to distinguish between medical and general

health/wellness use, MRC says, noting that a

device can be used for both. For instance, a

digital weight scale could be used for obesity

or cardiology care with the data uploaded to an

electronic health record at the physician’s of-

fice. But it also can be used by individuals

tracking their weight and body mass index,

who want to upload the information to a per-

sonal health record.

MRC also wants the agency to address the

challenges of the medical device accessory rule.

This rule was “logical and fairly easy to under-

stand when medical devices were mainly stand-

alone pieces of equipment and the rule applied

to products that end users … would physically

connect to the primary medical device,” the

group says.

In applying the accessory rule, the FDA

must address the “reality that network connectivi-

ty will be built into almost every medical device

going forward,” the group adds. — April Hollis

September 2010 THE GMP LETTER Page 9

Page 10 THE GMP LETTER September 2010

Devicemakers: Changes Necessary

In Draft Infusion Pump Guidance

Devicemakers are questioning several parts of

a draft guidance on infusion pumps that the FDA is-

sued as part of its first classwide action, and they’re

asking for more time to implement its provisions.

One of the provisions in the draft calls for

pre-clearance inspections of a company’s manu-

facturing facility.

Such inspections are unnecessary unless the

FDA has specific information that suggests a po-

tential problem, the Medical Device Manufactur-

ers Association (MDMA) says in one of 18 com-

ments on the guidance.

“If an inspection became a requirement for

510(k) clearance, this would result in a logjam

and FDA would be unable to conduct reviews in

a timely fashion,” the trade group adds.

When the FDA released the draft in April as

part of a multifaceted initiative targeting infusion

pumps, it said all of the suggestions in the guid-

ance would be effective immediately. The initia-

tive addresses numerous safety concerns about

the pumps, stemming from 56,000 medical de-

vice reports submitted in the past five years.

MDMA also is concerned that the draft does

not address specific types of infusion pumps, not-

ing that requirements for one type of pump may

not work for another.

For instance, the guidance includes proposals

dealing with software error messages, one of the

most frequent problems identified by the FDA.

“However, for some infusion pumps, re-

quirements pertaining to software are not rele-

vant,” MDMA says. “Therefore, before FDA is-

sues a final guidance, it must evaluate each infu-

sion pump to determine which elements of the

guidance should apply to it.”

A recommendation that manufacturers test their

infusion pump system with one FDA-approved drug

or biologic also is unnecessary and “unduly burden-

some,” the National Home Infusion Association says

in its comment.

Baxter suggests the FDA delay implementing

the guidance for 12 to 18 months so the agency

can clarify certain provisions. — Virgil Dickson

September 2010 THE GMP LETTER Page 11

New Zealand Devicemaker

Placed on Import Alert

Due to violations found during an FDA in-

spection late last year, the agency has placed prod-

ucts made by Molteno Ophthalmic on import alert.

The agency threatened the action in a May

11 warning letter posted online last month. The

Dunedin, New Zealand, company was listed on the

FDA’s import alerts page as of press time.

The warning letter, which stems from a Nov.

30 to Dec. 2 inspection, cites the company for fail-

ure to conduct a health hazard evaluation (HHE)

after multiple occurrences of black specks on the

plates of its Molteno 3 glaucoma drainage device.

An HHE was necessary to determine whether

there would be a risk if the specks migrated into a

patient’s eye after implantation, the warning letter

says. Molteno also failed to investigate to deter-

mine the root cause of the specks as part of a cor-

rective action request.

The FDA investigator noted the sterilization

validation for the implant was incomplete be-

cause it did not include stability testing of the de-

vice after moist heat sterilization to determine

whether the process adversely affects the device.

Molteno also was cited for issues involving its

corrective and preventive action procedure, process

validation, in-process product acceptance proce-

dures, medical device reporting procedures and pro-

cedures for identifying valid statistical techniques.

The company declined to comment. The

warning letter is available at www.fdanews.com/

ext/files/Molteno_WL.pdf. — April Hollis

Despite these missed windows, “the database is

not delayed,” Crowley told GMP, adding that tech-

nically it was “never on any particular timeline.”

Given the FDA’s track record on UDI, some

devicemakers are taking this latest release sched-

ule with a grain of salt, saying they will believe

progress is being made when something is pub-

lished in the Federal Register.

Devicemakers are in the dark about what is be-

hind all the delays. The only thing they know for

sure is that the UDI system will be based on exist-

ing open standards, such as those from GS1 and the

Healthcare Industry Communication Council, Jef-

frey Secunda, associate vice president of technology

and regulatory affairs at AdvaMed, told GMP.

Postmarket Safety

The UDI system, which would aid in post-

market device safety, is mandated by the FDA

Amendments Act of 2007.

Pressure on the FDA to develop a UDI system

is increasing, as regulatory agencies around the

world are realizing the need to develop their own

systems. Most recently, the Irish Medicines Board

issued a general advisory explaining the importance

of establishing an effective traceability system for

medical devices in all healthcare settings.

However, it is likely that most countries will

wait to see how the FDA proceeds, Secunda noted.

“The world will look to the FDA because it over-

sees the biggest device market,” he said. “What

the FDA says in the rule will influence how other

jurisdictions implement UDI.”

During a UDI workshop last year, the Ad-

vancing Patient Safety Coalition (APSC) took the

FDA to task over delays in developing the rule and

database, noting that the agency has been working

on the system since 2004 (GMP, August).

“That’s a good length of time. … There’s

been public meetings, there’s been reports com-

missioned — all good stuff. But again, what are

we waiting for?” APSC member Linda Rouse

asked at the meeting.

“Don’t think that we’re not very close to be-

ing done,” Crowley responded.

UDI Prototype

Ten months later, CDRH released the results

of a pilot version of the UDI program. While de-

vicemakers were receptive to the prototype, they

were concerned that it required information that

may be proprietary, unnecessary or not always

readily available.

CDRH announced in January that it expect-

ed it would begin to implement a UDI system by

Sept. 30, 2013. But when no progress was visible

by July, APSC sent a letter to FDA Commissioner

Margaret Hamburg asking that some sort of regu-

lation be released immediately. Its demand has

been met by silence, the group told GMP.

Crowley declined to explain why the agency

is struggling to release a proposed rule, saying, “It’s

a long, complicated process.” — Virgil Dickson

Page 12 THE GMP LETTER September 2010

UDI, from Page 1

President: Cynthia Carter; Publisher: Matt Salt; Editorial Director: Pamela Taulbee; Executive Editor: Mari Serebrov

Copyright © 2010 by Washington Business Information Inc. All rights reserved. The GMP Letter (ISSN 0196-626X), an executive briefing on FDAenforcement and quality systems requirements for medical devices and diagnostics, is published monthly, 12 issues, for $945. Photocopying orreproducing in any form, including electronic or facsimile transmission, scanning or electronic storage is a violation of federal copyright law and isstrictly prohibited without the publisher’s express written permission. Subscribers registered with the Copyright Clearance Center (CCC) may repro-duce articles for internal use only. For more information, contact CCC at www.copyright.com or call (978) 750-8400. For site licenses for multipleusers or to purchase multiple copies, contact Alka Desai at (703) 538-7669.

Reporters: David Belian, Virgil Dickson, LaCrisha Butler

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Since 2009, warning letter citations make clear that it’s no longer enough for you tolook back at the data and then react to quality problems.

You are now expected to trend your quality data. Your company may not havereceived such a citation ... yet. But every FDA inspection includes scrutiny of qualitymeasurement and trending mechanisms. The time to beef up your procedures isnow. Announcing the publication of Quality Data Trending: Requirements and BestPractices for Devicemakers.

This all-new special report from FDAnews shines the spotlight on this essential, but often neglected, area of qualitycontrol. In plain English, it:

■ Highlights the key regulatory requirements and recent enforcement actions ■ Reveals best practices to master a troubling regulatory standard■ Addresses sources of quality data, including minimums, and offers suggestions for

company-specific measures■ Walks you through the principal trending and statistical methodologies■ Spells out tried-and-tested reporting tools, dashboards and management review techniques■ Furnishes practical advice on when (and how) to perform

“deep dives” in search of meaningful data■ And much more!

Concerned about whether your data analysis methods will pass FDA muster?Stop worrying — and do something about it. Order your copy of Quality DataTrending now!

Quality Data Trending: Requirements and Best Practices for Devicemakers

METHOD OF PAYMENT❑ Check enclosed (payable to FDAnews)

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Add $10 shipping and handling per book for printed books shipped to the U.S. andCanada, or $35 per book for books shipped elsewhere. Virginia customers add 5%sales tax.

Please send me _____ copy(ies) of Quality Data Trending: Requirements andBest Practices for Devicemakers at $377 each for the format I’ve selected below:❑ Print ❑ PDF

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Attention drug and device manufacturers — the new health reform law is about to turn yourmarketing world upside down.

Under new rules, companies like yours must begin collecting data about payments to physi-cians. And that’s just the tip of the iceberg…

Here are just a few of the complexities you will soon begin to encounter …

■ Some states have banned payments and gifts to physicians outright; others have restricted certain marketing techniques

■ These state laws may not be preempted by the new federal law

■ Some state laws may even apply to nonphysicians too — therapists, nurse practitioners, P.A.’s and others

■ Certain individual medical facilities are imposing their own restrictions on allowable marketing practices.

To top things off, compliance is required by the end of 2011 — and, if you fail to comply, you run the risk of fines up to $1 million.

It’s enough to drive a drug or device marketing official to seek guidance and information. That guidance and information is now available in the all-newManagement Report from FDAnews, Physician Payment Compliance: A Guide to State and Federal Laws for Drug and Device Companies.

Physician Payment Compliance:A Guide to State and Federal Lawsfor Drug and Device Companies

METHOD OF PAYMENT❑ Check enclosed (payable to FDAnews)

❑ Bill me/my company. Our P.O.# _____________________❑ Charge my credit card:

❑ Visa ❑ MasterCard ❑ American Express

Credit card no. _______________________________________

Expiration date _______________________________________

Signature _______________________________________(Signature required on credit card and bill-me orders)

10FLYR

Add $10 shipping and handling per book for printed books shipped to the U.S. andCanada, or $35 per book for books shipped elsewhere. Virginia customers add 5%sales tax.

Please send me _____ copy(ies) of Physician Payment Compliance at $377 eachfor the format I’ve selected below:❑ Print ❑ PDF

❑Yes!✓

1. PHONE: Toll free (888) 838-5578or +1 (703) 538-7600

2. WEB: www.fdanews.com/32792

3. FAX: +1 (703) 538-7676

4. MAIL: FDAnews300 N. Washington St., Suite 200Falls Church, VA 22046-3431

FOUR EASY WAYS TO ORDER

Name _________________________________________________________

Title __________________________________________________________

Company ______________________________________________________

Address _______________________________________________________

City__________________________________ State ____________ Zip code __________

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Email _________________________________________________________