http://MedicalDeviceEvents.com At the 10x Medical Device Conference in 2014, presenters Carrie Kuehn, Jorge Ochoa, and Robert Packard explained why, according to data from FDA, more than 58% of 510(k) submissions were refused under FDA’s Refuse to Accept (RTA) policy during its first year of implementation. This presentation examined some of the reasons why industry got such a bad “grade.” We discussed the RTA requirements and some of the challenges from industry’s perspective on meeting the requirements of the RTA checklist and ended with recommendations on how industry can improve its odds of getting past the RTA hurdle on the first try.

1. 1
Why Did the FDA Refuse Nearly 60% of
All 510(k) Submissions in 2013?

2. 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. 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. 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. 5
The RTA Checklist

6. 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. 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 Failure to comply with a Draft Guidance document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. 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. 9
Medical Device New Product Development

10. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 20
Thank you!
Questions & Discussion