1

Why Did the FDA Refuse Nearly 60% of

All 510(k) Submissions in 2013?

2

Introductions

Rob Packard – Founder/President, Medical Device Academy, Inc.

Carrie M. Kuehn, M.P.H., RAC – Sr. Managing Scientist, Biomedical Engineering Practice,

Exponent

Jorge Ochoa, Ph.D., P.E. – Principal, Biomedical Engineering Practice, Exponent

3

FDA’s Refuse to Accept Policy

FDA criteria for assessing whether a 510(k) meets minimum requirements for substantive review

Final Guidance issued December 31, 2012

Purpose:

– Focus FDA resources on review of complete 510(k)s

– Enhance consistency of acceptance decisions

– Assess completeness, not quality, of submission

FDA will respond within 15 days of receipt

4

Administrative vs. Substantive Review

Administrative

Is it a device?

Are MDUFA fees paid?

Is the 510(k) the right submission?

Presence or absence of required 510(k) components

Results in RTA or Substantive Review

Substantive

Quality of 510(k) components

Adequacy of submission

SE determination

Additional information requests

Interactive review

Results in Binding Determination of SE

“No evaluation of adequacy of content or rationale”

- Marjorie Shulman, Director 510(k) Staff, FDA

5

The RTA Checklist

6

FDA’s 2013 Annual 510(k) Performance

2,965 510(k)’s received in 2013

1,197 Accepted

1,715 Refuse to Accept

Rate of Submissions Not Accepted

58%

Quarterly Meeting on MDUFA III (FY 2013-2017) Performance. January 29, 2014

7

Reported Reasons for Refusal

Failure to state whether a condom was patient contacting

Failure to explain how following the Specials Control Guidance Document for labeling met the labeling requirements under 21 CFR §807.87

510(k) Summary formatting comments

Failure to comply with a Draft Guidance document

Failure to indicate whether a vinyl glove contained software or met the electrical safety requirements

Substantive questions regarding shelf-life and other content that should be the subject of review not RTA

Typos, misprints, duplicate pages, etc.

FDA Law Blog. February 26, 2014

8

More Detail Needed than Ever Before…

“We didn’t need to include that last time.”

“But that’s not applicable.”

“Do we need to provide that? It should be obvious.”

9

Medical Device New Product Development

10

Industry Report Card:

What the FDA Saw* 2001 - 2010

Increase in average number of review cycles from 2001 to 2010

Increase in industry time to react to questions and deficiencies

83% of AI letters had at least one quality related deficiency

– Inconsistencies in the submission

– Missing admin requirements

Old RTA checklist very rarely used

– Not descriptive enough

– No effect on the review clock *Marjorie Shulman, Director 510(k) Staff, FDA. FDLI 2013

11

What RTA Means to Industry

Careful what you ask for…

– Reduce number of review cycles and total time to final decision = you get ONE shot at it

New checklist criteria

– Compilation of regulations, statutes, guidance, review practices = addition, not intersection

– Objective tool to understand key components of complete submission = its important to us, so its important to you

– Only evaluating presence, not adequacy, in principle

Efficient use of reviewer resources = more work on your part

12

How Are NPD Projects Affected?

If rejected: FDA clock stops and resets to day 0 when RTA response received

RTA review is not an interactive process

Unlimited number of RTA cycles

Concept of Substantive Interaction (SI)

Missed MDUFA Decision (MMD) communication

Schedules and resources will be influenced.

Effect can be cumulative

13

Training Your Resources

Make the 510(k) an integral part of your NPD work breakdown structure

– All you need for your RTA checklist and 510(k) should be in your DHF and project manager’s notebook

Ensure that all NPD team members and functions are conversant in regulatory terminology and concepts

Train personnel interacting directly with FDA on effective communication skills

– Substantive Interaction (SI) decision

– Interactive Review (IR) process

14

Risk for RTA Letter

High RTA Risk

11 – Device Description

12 – Substantial Equivalence

Moderate RTA Risk

5 – 510(k) Summary or 510(k) Statement

9 – DCs & Summary Reports

10 – Executive Summary

13 – Proposed Labeling

14 – Sterilization and Shelf Life

15 – Biocompatibility

16 – Software

17 – Electromagnetic Compatibility & Electrical Safety

18, 19, & 20 – Performance Testing (Bench, Animal, Clinical)

Low RTA Risk

1 – Medical Device User Fee cover Sheet

2 – CDRH Premarket Review submission Cover Sheet

3 – 510(k) Cover Letter

4 – Indications for Use Statement

6 – Truthful and Accuracy Statement

7 – Class III Summary & Certification

8 – Financial Certification or Disclosure Statement

15

Volume 9 – Declaration of Conformity (Part A)

FDA Form 3654 (http://bit.ly/Form-FDA-3654)

– Completed for all listed standards

– If two revisions are shown, only the most recent

Recommend a Summary Document

– List all Form 3654s

– List corresponding reports for each 3654

Device-specific guidance and/or special controls

– Create a table showing how each requirement is met

16

Volume 12 – Substantial Equivalence (Part C)

Comparison with Predicate Device(s)

Tabular Format

Contents Include Similarities AND Differences

– Indications for use & Patient population

– Technology

– Mode of Action & Functionality

– Materials

– Size

Safety & Efficacy

http://bit.ly/Substantial-Equiv-Guidance

17

Identifying A Predicate Device

513(g) Submission (http://bit.ly/513g-guidance)

Pre-Submission Meeting (http://bit.ly/FDA-Pre-Sub)

Critical Points of Comparison

– Intended Use & Patient Population

– Technology

– Mode of Action & Functionality

18

Volume 11 – Device Description (Part B)

Device-specific guidance and/or special controls

Consistent with labeling

Principle of operation and mechanism of action

Conditions of use

Each device within submission

Drawings and schematics

Components and accessories—including 510(k)s

19

Other Parts of RTA Checklist

Part D – Labeling (Device Specific?)

Part E – Sterilization (Novel or Non-traditional Methods?)

Part F – Shelf-Life

Part G – Biocompatibility

Part H – Software (Level of Concern & Risk Analysis)

Part I – EMC & Electrical Safety (IEC 60601-1 3rd Ed. Amd 1)

Part J – Performance Data (Special Controls?)

Part K – Performance Characteristics (IVDs only)

20

Thank you!

Questions & Discussion