510(k) Process:

Best Practices in Changing Times…

MassMEDIC Massachusetts Medical Society, Waltham, MAApril 1, 20108:00 AM - 10:30 AM

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510(k) ProcessBest Practices in Changing Times

Welcome: Tom Sommer MassDevice (www.massdevice.com) Overview of the 510(k) Process: Rosina

Robinson, MDCI 510(k) Pathways: Terry Sullivan, Gyrus/ACMI 510(k) Submissions to CBER: Sue Finneran,

Haemonetics Corp. FDA/Congressional Update on Plans for

510(k) Program - Paul Kim, Foley Hoag

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Breaking news from CNN at 7:45 AM…

CDRH plans to rescind clearance of all premarket notifications for all currently marketed Class II and III devices and will require resubmission of information according to new requirements to be defined later today…

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Breaking news…

April Fool

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510(k) Process: Best Practices in Changing Times

"The only things certain in life are death and taxes.” Benjamin Franklin

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510(k)s: Why are we here today?

Questionable rigor of the 510(k) process and effectiveness of regulation of the industry has created an environment of uncertainty. Failure of FDA to take final classification action on all

pre-amendment Class III devices currently cleared by 510(k) – Manufacturers of final group of devices required to submit data summer 2009

Perceived conflict of interest created by industry payment of review user fees to the FDA

Alleged coercion of review staff Questionable quality of 3rd party review program

What’s next? Creation of internal task force IOM investigation with report due March 2011

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What is a medical device? Per Chapter 2, §201(h) of Food, Drug, and Cosmetic Act, as amended:

A medical device is an instrument, apparatus, implement, machine, contrivance, implant, or in vitro reagent

Intended to: Diagnose diseases/conditions;

Cure, mitigate, treat, or prevent disease;

Affect the structure/function of the human body; and …

Does not achieve primary purpose through chemical action in or on the body.

Is not dependent upon being metabolized for its primary purpose.

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510(k) – Statutory Basis

SEC. 510. [21 USC §360] Registration of Producers of Drugs and Devices Report preceding introduction of devices

into interstate commerce. Persons required to register who proposes to introduce

device for human use into interstate shall report at least ninety days before (1) the class in which the device is classified under

section 513; If not classified, a statement of that determination and the basis for the determination and

(2) action taken by such person to comply with requirements under section 514 or 515 which are applicable to the device.

…

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510(k) – Regulations

21 CFR 807.90 Format of a premarket notification 42 FR 4256, August 23, 1977, as

amended at 53 FR 11252 April 6, 1988

55 FR 11169, March 27, 1990

65 FR 17137, March 31, 2000

70 FR 14986, March 24, 2005

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510(k) – Regulations

21 CFR 807.92 Content and format of a 510(k) summary 57 FR 18066, April 28, 1992, as amended at

59 FR 64295, December 14, 1994

21 CFR 807.93 Content and format of a 510(k) statement 59 FR 64295, December 14, 1994

21 CFR 807.94 59 FR 64296, December 14, 1994 …

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510(k)s – “Guidance”

Guidance document database (includes Special Controls) http://www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/GuidanceDocuments/default.htm

Standards database http://www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/Standards/default.htm

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

PRIMARY CENTER & CPsPRIMARY CENTER & CPs

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

PRIMARY CENTER & CPsPRIMARY CENTER & CPs

FDA Centers with FDA Centers with Product Review and Compliance ResponsibilitiesProduct Review and Compliance Responsibilities

(CP=Combination products)(CP=Combination products)

FDA Centers with FDA Centers with Product Review and Compliance ResponsibilitiesProduct Review and Compliance Responsibilities

(CP=Combination products)(CP=Combination products)

Center for Food Safety Center for Food Safety and Applied Nutrition (CFSAN)and Applied Nutrition (CFSAN)

Center for Food Safety Center for Food Safety and Applied Nutrition (CFSAN)and Applied Nutrition (CFSAN)

Center for Veterinary Center for Veterinary Medicine (CVM)Medicine (CVM)

Center for Veterinary Center for Veterinary Medicine (CVM)Medicine (CVM)

Center for DrugCenter for DrugEvaluation and Research (CDER)Evaluation and Research (CDER)

CPsCPs

Center for DrugCenter for DrugEvaluation and Research (CDER)Evaluation and Research (CDER)

CPsCPs

Center for BiologicsCenter for BiologicsEvaluation and Research (CBER)Evaluation and Research (CBER)

DESIGNATED DEVICESDESIGNATED DEVICES & CPs & CPs

Center for BiologicsCenter for BiologicsEvaluation and Research (CBER)Evaluation and Research (CBER)

DESIGNATED DEVICESDESIGNATED DEVICES & CPs & CPs

FDA oversight for medical devices authorized by 1976 Medical Device Amendments of 1976 (§513, FD&C Act, as amended)

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510(k)s - The Past

Class I Exempt from pre-market

notificationClass II

510(k) premarket notification Class III

Class III 510(k) for pre-amendment devices for which PMAs have not yet been announced

Relative regulatory

burden

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510(k)s – Key Changes

Then: Simple notification to the FDA of planned marketing 90 days before introduction of the device into interstate commerce Now: Prohibition from marketing without explicit

written clearance

THEN: Regulatory information limited to information requested under FOI. NOW: Enforcement of 510(k) Summary content or

compliance with 510(k) Statement obligations.

FUTURE?: Change to on-line 510(k) database to allow easier identification of predicate/s.

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510(k)s – Key Changes…

THEN: Only the FDA can review 510(k)s. NOW: Use of Accredited Persons for 510(k) review

(except for those including clinical data)

FUTURE?: Elimination of program?

THEN: No Medical Device User Fee NOW: Medical Device User Fees for review of

premarket submissions for medical devices (with Small Business reductions or Third Party review)

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510(k)s - The Present

Class I Exempt from pre-market notification

unless specifically reservedClass II

510(k) premarket notification -Traditional, Abbreviated, or Special unless specifically exempt – may include clinical data (March 1998)

510(k)s cleared in FY2008: 3,058 (2 by DeNovo; 23 with clinical trials; FY 2009, 250 by third party review)

Class III 510(k)s: Preamendment Class III devices for

which premarket approval applications have not been announced – Now but maybe not for long…

Relative regulatory

burden

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510(k)s - The Present

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510(k)s - The Future

Class I Exempt from pre-market

notification unless specifically reserved

Class II 510(k) premarket notification -

Traditional, Abbreviated, or Special unless specifically exempt – may include clinical data (March 1998)

Class III - NO 510(k)

Relative regulatory

burden

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510(k)s – The Future

Buzzwords at February 9 and February 18 FDA public meetings: Transparency

Predictability

Adaptability

Can industry expect the CDRH to meet these goals? What will it take?

Has the integrity and usefulness of the current pre-IDE process been compromised?

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510(k)s – The Past – What about the future?

Pre-IDE process Potential Benefits

More formal than isolated telephone call or email

Establishes point/s of contact with review staff

Can identify Agency concerns before submission/s made

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510(k)s – The Past – What about the future?

Pre-IDE process…

Limitations:

Minimizes but does not always prevent later surprises

Does not provide an in-depth review or formal Agency commitment to final requirements or acceptance

Things change…

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510(k) Process: Best Practices in Changing Times

What can we do to address today’s and future uncertainty? Take a step back

and return to the basics

Share ideas with colleagues

Stay current with rapidly changing environment

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510(k)s: Preview of things to come?

FDA March 23, 2010 Meeting of the Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee. Advisory Panel for reevaluation of the ReGen Collagen Scaffold (CS) device

http://www.foxbusiness.com/story/markets/industries/technology/update-fdanot-data-regen-knee-device-safe/

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510(k)s: What will the future bring?

http://web.ics.purdue.edu/~ssanty/cgi-bin/eightball.cgi

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510(k)s: The last word

“The only certainty is that nothing is certain.” Pliney, the Elder

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510(k) Process: Best Practices in Changing Times

Welcome: Tom Sommer MassDevice Overview of the 510(k) Process: Rosina

Robinson, MDCI (robinson@mdci.com) 510(k) Pathways: Terry Sullivan,

Gyrus/ACMI 510(k) Submissions to CBER: Sue

Finneran, Haemonetics Corp. FDA/Congressional Update on Plans for

510(k) Program - Paul Kim, Foley Hoag