Center for Devices and Radiological Health(CDRH)(CDRH)

Regulatory Structure & Resources

NIH SBIR/STTR Conference Louisville KYLouisville, KYMay 31, 2012

Stanley LiuConsumer Safety Officer

Center for Devices and Radiological HealthFood and Drug Administration

This Presentation is not intended to be all inclusive.

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CDRH MissionFoster Foster innovationinnovation, , and get safe and and get safe and effective devices to effective devices to

… while ensuring … while ensuring that medical that medical

d i tl d i tl effective devices to effective devices to market as market as quicklyquicklyas possible…as possible…

devices currently devices currently on the market on the market

remain remain safesafe and and effectiveeffective..

Protect the public from electronic product radiationProtect the public from electronic product radiation

Provide the public with scienceProvide the public with science--based accurate information on based accurate information on medical devices and radiological products medical devices and radiological products

22March, 2012March, 2012 Guidance for Industry and FDA Staff Guidance for Industry and FDA Staff –– Factors to Consider when Making Factors to Consider when Making

BenefitBenefit--Risk Determinations in Medical Device ReviewsRisk Determinations in Medical Device Reviews

Definition of CDRH Regulated ProductsProducts

• Medical device: Section 201(h) of theMedical device: Section 201(h) of the Federal Food, Drug and Cosmetic Act (FDCA)(FDCA)

• Radiation emitting electronic product:Section 531 of the FDCA

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FDCA S ti 201(h)FDCA Section 201(h)A medical device isA medical device is…

– an instrument, apparatus, …or other similar or related article including any component part orrelated article, including any component, part, or accessory

– intended for use in the diagnosis of disease orintended for use in the diagnosis of disease or other conditions, or in the cure, mitigation,treatment, or prevention of disease, in man or pother animals, or

– intended to affect the structure or any function of the body of man or other animals, and

– does not achieve its primary intended purposes th h h i l ti b i t b li d

4through chemical action, or being metabolized

Regulatory OverviewThree Phases:

1. Premarket• 510(k) exempt, 510(k), PMA, HDE, etc.

2. Registration/Listing• Registration, Listing, Annual Fee, etc.

3. Postmarket• Quality Systems/GMP, MDR, recalls, etc.

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Device Classification• Classification determines extent of regulatory control (Risk

Based)1 700 i t f d i d i t 16 di l• 1,700 generic types of devices grouped into 16 medical specialties (21 CFR 862 to 892)

• The U S FDA classifies devices according to risk into• The U.S. FDA classifies devices according to risk into three classes: – Class I (low to moderate risk): general controls (registration &Class I (low to moderate risk): general controls (registration &

listing, premarket notification, good manufacturing practices, etc.)

– Class II (moderate to high risk): general and special controls (device-specific guidances, consensus/performance standards)

6– Class III (high risk): general controls, as well as a Premarket Approval (PMA).

Product Codes• Devices within the same classification may have

differences in intended use or technologicaldifferences in intended use or technological characteristics. Product code is assigned to each of these devices for further differentiation

• For example, “medical support stocking:” 21CFR 880.5780– Product code DWL: Medical support stocking to prevent the

pooling of blood in the legs. Class II and requires 510(k)pooling of blood in the legs. Class II and requires 510(k)– Product code FLL: Medical support stocking for general medical

purposes. Class I and is exempt from 510(k)

Jan 3, 2012: Jan 3, 2012: Draft Guidance Draft Guidance -- Medical Device Classification Product CodesMedical Device Classification Product Codes

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General Controls• Stated in FDCA Section 513(h)(1), such as:

P hibiti f Ad lt ti / Mi b di– Prohibition of Adulteration / Misbranding

– Premarket Notification [510(k)], unless exempted

El t i E t bli h t R i t ti & Li ti– Electronic Establishment Registration & Listing

– Quality System Regulation

L b li– Labeling

– Medical Device Reporting (MDR)

R t f C ti d R l– Report of Corrections and Removals

– Regulations for Investigational Devices

D i T ki8

– Device Tracking

Special Controls• Class II devices are those for which general controls alone are

insufficient to assure safety and effectiveness.insufficient to assure safety and effectiveness.– Special Control Guidelines – Special Control Guidance

– Mandatory Performance Standard

– Special Labeling (e.g., 884.5300 Male Condom)

– Mandatory Postmarket Surveillance

– Recommendations or Other Actions

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P k t N tifi tiPremarket Notification 510(k)510(k)

• Marketing Clearance Process • Application submitted at least 90 days before

marketing• Demonstration of Substantial Equivalence

(SE) to legally marketed device in U.S.( ) g y• Substantial Equivalence means: Just as

Safe and Just as Effective10

Safe and Just as Effective

When is a 510(k) Required?

• Determined by classification• Determined by classification– Marketing for first time, or – Significant change to 510k cleared

devicedevice

J 10 1997 (C t) G id D idi Wh t S b it 510(k) f Ch tJanuary 10, 1997 (Current) Guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device (K97-1)

July 27, 2011 (Draft) Guidance: Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device

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510(k) Device User Fees• 510(k) fee in U.S. Dollars for fiscal

year 2012

– Standard Fee $4,049S ll B i F $2 024– Small Business Fee $2,024(≤$100 million in gross receipts or sales)

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Type of 510(k) Submission• Traditional 510(k) – standard, original complete

b i i C b d f 510ksubmission. Can be used for any 510k • Abbreviated 510(k) - Conformance with special

controls, guidance or consensus standards • Special 510(k) –For 510k modification if the p ( )

modification does not affect the intended use or the fundamental technology of the device. gyConformance to Design Controls to assure SE for device modifications

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R i C t t d F t fReview, Content, and Format of 510(k)510(k)

• Office of Device Evaluation (ODE)Offi f I Vit Di ti D i (OIVD)• Office of In Vitro Diagnostic Devices (OIVD)

• Third Party Program (Accredited Persons)-d t li i i li ibl d iconduct preliminary review on eligible devices

• FDA Device Advice has detailed guidance on how to prepare and submit Premarket N tifi ti (510k)Notification (510k)

A t 12 2005 G id F t f T diti l d Abb i t d 510(k)14

August 12, 2005 Guidance: Format for Traditional and Abbreviated 510(k)s

Premarket Approval (PMA)• Only applies to Class III devices when

classification requires PMA

Device Not “SE” to legally marketed• Device Not “SE” to legally marketed devicesdevices

• Must prove reasonable assurance of

safety and effectiveness15

PMA Device User FeesPMA Device User Fees (2012)(2012)

• Standard Fee USD $220,050

• Small Business Fee for First application

– ≤$30 million Fee is Waived≤$100 million USD $55 013– ≤$100 million USD $55,013

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Purpose of Design ControlPurpose of Design Control

• To control the design process to assure that the devices meet:meet:-User needs -Intended uses -Specified requirements (following appropriate risk analysis)

• The design control requirements are not intended to apply to development of concepts or feasibility studies.

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Design and DevelopmentDesign and DevelopmentUser REVIEW

Design

UserNeeds

REVIEW

Design

Design Input

Design Process

DesignDesignOutput

Medical

VERIFICATION

Medical Device

VALIDATION

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Investigational Device E ti (IDE)Exemption(IDE) “Clinical Trials”Clinical Trials

• Clinical investigations of devices to collect safety and effectiveness data

• Must comply with the cGCPs and• Must comply with the cGCPs and design controls (21 CFR 820.30)

• Protect human subjects & ensure validity of clinical study

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y y

Establishment Registration & M di l D i i i& Medical Device Listing

• Electronic registration of device firmg– Foreign firm must have a U.S. Agent

Electronic listing of medical device• Electronic listing of medical device• Oct. – Dec., Annual Registrationg

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Quality System (QS) Regulation

(21 CFR 820)(21 CFR 820)• Quality Assurance System covering the• Quality Assurance System covering the

design, manufacture, installation and servicing of medical devices distributedservicing of medical devices distributed in the U.S. (Si il t ISO 13485)• (Similar to ISO 13485)

• Standard for audit of device establishment21

Medical Device LabelingMedical Device Labeling

• Labeling: Any label or written material on the device or accompanying theon the device or accompanying the device

• Labeling must provide adequate directions for use unless exemptdirections for use unless exempt

• Labeling must not be false or i l di

22misleading

Medical Device Reporting (MDR)

“Adverse Event Reporting”Adverse Event Reporting

• Mechanism for FDA to identify and monitor adverse events involving medical devicesad e se e e s o g ed ca de ces

Events: Death, Serious Injury and Malfunction

Reported by: Manufacturer, User Facility, and Importers of medical devices

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Importers of medical devices

Corrections & Removals• Manufacturer or importer must report and

keep record on correction or removal of device if the removal or correction was – to reduce a risk to health posed by the device,

oror– to remedy a violation of device which may

present a risk to healthpresent a risk to health

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Who We Are…• DSMICA is a Division in CDRH’s Office of Communication,

Education and Radiation Programs (OCER)g ( )– Currently 20 employees:

• Division Director, Mr. Elias Mallis• Medical and scientific professionals• Medical and scientific professionals• Industry experts• International affairs specialists• Consumer communications specialists• Email: dsmica@fda.hhs.gov• Phone: 800-638-2041 or 301-796-7100• Phone: 800-638-2041 or 301-796-7100• Fax: 301-847-8149• Monday - Friday 8:00 a.m. to 5:00 p.m. EST

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Who We Are (continued)…• Email: dsmica@fda.hhs.gov• Phone: 800-638-2041 or 301-796-7100• Fax: 301-847-8149• Monday - Friday 8:00 a.m. to 5:00 p.m.

ESTEST

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What We Do…• Answer inquiries and provide regulatory and

educational assistance to stakeholders on questions l t d t d i d l t i d t d th irelated to device and electronic products and their

regulation• Distribute important safety notices via e mails and• Distribute important safety notices via e-mails and

letters to CDRH Stakeholders• Function as the CDRH liaison for the implementation• Function as the CDRH liaison for the implementation

of the Third Party Programs

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What We Do (continued) …• Coordinates international activities, harmonization

and capacity building• While founded in the law, our function is based on the

belief that education fosters voluntary compliance

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Small Business D t i ti (SBD )Determinations (SBDs)

• Applicant that qualifies as a small business f fis eligible for reduced review fees

• FDA reviews application within 60 days ofFDA reviews application within 60 days of receiptS ll B i t t i t th d f• Small Business status expires at the end of the fiscal year

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Device Advice Website• Self-service site for medical device and

di ti itti l t i d tradiation-emitting electronic product information, including– Is my product a medical device?– What is device classification?What is device classification?– How to market your device?

P t k t i t– Postmarket requirements– Import/Export

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p p• http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance

CDRH Learnwww fda gov/cdrh/cdrhlearnwww.fda.gov/cdrh/cdrhlearn

• Newest Online Resource for Industry Education

• Course lists include:– Overview of Regulatory Requirements: Medical Devices

G id D t d SOP– Guidance Documents and SOPs– Quality System Regulation – Device Establishment Registration and Listing– Overview of the Premarket Notification Process – 510(k)– How to Get Your Electronic Product on the U.S. Market– Bioresearch Monitoring (BIMO)g ( )

• Some translated into Chinese and Spanish. • Post training test available

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Post training test available

Important New Draft and Final GuidancesGuidances

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm

1. Apply Human Factors & Usability in Device Design (DRAFT Jun. 22, 2011)

2. Benefit-Risk Determinations in Premarket Review (DRAFT Aug. 15, ( g2011, FINAL Mar. 28, 2012)

3. De Novo Guidance (Oct. 3, 2011)4. IDE for Early Feasibility Studies (DRAFT Nov. 10, 2011)

5. Evaluation of Sex Differences in Device Trials (DRAFT Dec. 19, 2011)6. Evaluating SE in 510k (DRAFT Dec. 27, 2011) 7 Product Code Guidance (DRAFT Jan 03 2012)7. Product Code Guidance (DRAFT Jan. 03, 2012)

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