Transcript Slide 1

510(k) Process:
Best Practices in Changing Times…
MassMEDIC
Massachusetts Medical Society, Waltham, MA
April 1, 2010
8:00 AM - 10:30 AM
510(k) Process
Best 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
2
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
4
510(k) Process:
Best Practices in Changing Times
"The only things
certain in life are
death and taxes.”
Benjamin Franklin
5
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 preamendment 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.
…
8
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/DeviceReg
ulationandGuidance/GuidanceDocuments/defa
ult.htm

Standards database
 http://www.fda.gov/MedicalDevices/DeviceReg
ulationandGuidance/Standards/default.htm
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FDA Centers with
Product Review and Compliance Responsibilities
(CP=Combination products)
Center for Devices
and Radiological Health (CDRH)
PRIMARY CENTER & CPs
Center for Biologics
Evaluation and Research (CBER)
DESIGNATED DEVICES & CPs
Center for Drug
Evaluation and Research (CDER)
CPs
Center for Veterinary
Medicine (CVM)
Center for Food Safety
and Applied Nutrition (CFSAN)
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
Relative
regulatory
burden
I
 Exempt from pre-market
notification
 Class
II
 510(k) premarket notification
 Class
III
 Class III 510(k) for preamendment devices for which
PMAs have not yet been
announced
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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

Relative
regulatory
burden
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)
 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…
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510(k)s - The Present
17
510(k)s - The Future
 Class
Relative
regulatory
burden
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)
18
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/i
ndustries/technology/update-fdanot-dataregen-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
25
510(k) Process:
Best Practices in Changing Times

Welcome: Tom Sommer

MassDevice

Overview of the 510(k) Process: Rosina
Robinson, MDCI ([email protected])

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
26