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
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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 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.
…
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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/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
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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)
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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/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
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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 ([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
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