FDA REFUSE TO ACCEPT POLICY FOR 510(k)s:

Overview

Juan Carlos Serna, VP

Brian Young, VP, Regulatory/Quality

September 25, 2015

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HPA Presenters

Juan Carlos Serna – Vice President, HPA• 15 years of experience in leading FDA-regulated companies

in the areas of compliance, quality assurance, preclinical and clinical biotechnology development, clinical trials, and regulatory affairs.

Email: jcserna@healthpolicyassociates.com

Brian Young – Vice President, Regulatory Affairs, HPA• 30 years of diversified work experience in the medical

device and diagnostic industry. He is the former Vice President of Global Regulatory and Clinical Affairs at Kinetic Concepts, Inc.

Email: byoung@healthpolicyassociates.com

Overview

• FDA Refuse to Accept (RTA) Policy

• RTA Background and History

• What Industry can do to improve the likelihood of 510(k) acceptance

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Out of Scope

• Pre-Submission Meetings

• Substantial Equivalence approaches

• eCOPY Program

• Device Specific Guidance

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FDA Refuse to Accept Policy

Detailed checklist used by FDA staff to determine if a submission is administratively complete.

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RTA Intent

• Reduce review cycles and total time to decision

• Efficient use of FDA resources

• Reward complete submissions

• Only evaluating presence, not adequacy of data

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RTA Facts

• 15 calendar days

• RTA review has not been an interactive process

• If RTA issued, review clock resets to Day 0

• There is no limit on the number of RTA cycles

• Avg. FDA days time to RTA1 decision: 10.8*

• Avg. Manufacturer days to respond: 21*

* FDA 510(k) RTA Internal Audit February – April 2014

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Acceptance Checklist History

FDA checklist prior to December 31, 2012:

1 Page December 31, 2012 Traditional RTA checklist:

26 Pages August 4, 2015 Traditional RTA Checklist*:

24 Pages

* Goes into effect October 1, 20158

Why more comprehensive RTA checklists?

• MDUFA goals a driving force

• RTA is a power tool for FDA to screen non-viable submissions early

• “checklists seem able to defend anyone, even the experienced, against failure...”― Atul Gawande, The Checklist Manifesto: How to Get Things Right

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RTA Checklist Impact

• CDRH rate of submissions not accepted after implementation of the checklist:

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Quarterly Update on Medical Device Performance Goals: MDUFA III Performance Data, Action through 31 March 2015

Early Problems with 2012 RTA Guidance and/or its Implementation

• Is a condom patient contacting?– If so, whether it was for more or less than 24 hours

• Does a vinyl patient exam glove contain software or meet electrical safety requirements?

• Failure to provide a clearly labeled ‘SE comparison discussion’

• Failure to comply with draft guidance• Failure to provide a rationale to support a 6

month shelf life claim• Typos and misprints, e.g., two page 75s

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Hyman Phelps & McNamara FDA Law Blog “Reflecting on the first year of CDRH’s 510(k) refuse to accept policy”, February 26, 2014.

Causes for Changes in RTA Rates

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New, New and Improved RTA

• Reviewer discretion written into the guidance:

– To determine whether missing checklist elements are needed

– May request missing checklist elements interactively from submitters

• Checklist revised to improve clarity, reduce elements which may lead to substantive review, and improve usability for industry

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What Industry Can Do To Improve the Likelihood of Acceptance / Tips

“the volume and complexity of what we know has exceeded our individual ability to deliver its benefits correctly, safely, or reliably.”― Atul Gawande, The Checklist Manifesto: How to Get Things Right

• Invest time early - follow checklist and 510(k) format guidance

• Include the RTA checklist with the application, identify page numbers where requirement is included

• Provide data-driven rationales for any missing information• Perform an independent verification• Pay extra attention to areas that have historically been

reasons for RTA rejection• Seek clarification if you are uncertain

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Pareto – Top 10 Missing Criteria

40

3331 31

28 27

24 24 24

19

0

5

10

15

20

25

30

35

40

45

RTA Rate (%)

From Feb-April 2014 FDA 510(k) RTA Audit. Question numbers refer to new 2015 checklist. 15

Divisions with Highest Rejection Rates (as of June 30, 2015)

Division 2013 2014 2015

Neurological and Physical Medicine Devices 79% 58% 56%

Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices

69% 57% 50%

Division of Ophthalmic and Ear, Nose and Throat Devices

46% 46% 44%

Division of Orthopedic Devices 65% 52% 43%

Division of Surgical Devices 63% 54% 36%

Division of Cardiovascular Devices 52% 49% 36%

Quarterly Update on Medical Device Performance Goals: MDUFA III Performance Data, Action through 30 June 2015

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