CDRH Update Key Data and Current Issues IMDMC Annual Meeting

1. CDRH UpdateKey Data and Current IssuesIMDMC Annual Meeting November 7, 2013 Ralph F. Hall Counsel Faegre Baker Daniels Professor of Practice University of Minnesota Law School

2. Agenda • Current CDRH review performance • Time for review • RTA • De novo • Modifications • Management assessment • OC reorganization • Key upcoming guidances • Case for Quality • Shutdown impact

3. Average Time to Decision: 510(k)s*- Comparison of Receipt Cohorts When 97.6% Closed - *SE and NSE decisions only; times may not add to total due to rounding **FY 2013 cohort is not yet 97.6% closed (as of 09/30/2013)

4. Percent of 510(k)s With Additional Information (AI) Request on 1st FDA Review Cycle (9 mos.) *FY 2013 data are based on the first substantive review cycle, i.e., excluding RTA cycles

5. Percent of 510(k)s Determined to be Substantially Equivalent (SE) *Excludes final decisions made on FY 2013 receipts that were not accepted for substantive review

6. Percent of PMAs With Major Deficiency Letter (MAJR) on 1st FDA Review Cycle* (9 mos.) *Includes original PMAs filed as of 06/30/2013; FY 2013 excludes 3 PMAs with 1st cycle incomplete

7. Average Time to MDUFA Decision: PMAs*- Comparison of Filed Cohorts When Approx. 92% Closed** - *Includes all filed original PMAs; times may not add to total due to rounding **Proportion of cohort closed (MDUFA decision): FY07 = 32/35; FY08 = 28/30; FY09 = 29/32; FY10 = 40/43; FY11 = 40/43; FY12 = 22/24

8. Percent of PMAs Approved* *Based on original PMAs that were accepted for filing

9. Other Submission Data • Pending 510(k)s • 1,402 pending as of 9/30/13 • At 2007 level • Down from 2010 high of 1,917 • Refusal to Accept (RTA) • 1st pass rejection rate of 58% for 510(k)s • Increasing use of de novo • Historically 5-10 de novos per year • FDASIA improved de novo process • 46 de novos in FY 2013 • 31 direct de novos/15 post NSE de novos

10. Modifications • Key initial CDRH project • 2011 draft guidance • Substantial push back • Triggered excessive number of submissions • FDASIA §604 • Required withdrawal of draft guidance • Report to Congress due January 2014 • Draft guidance no earlier • Final guidance at least one year later • Documentation challenges in some companies

11. Modifications • Report being prepared • Expected Jan. 2014 • Current predicted approach • Maintain K97-1 concepts • Maintain rough number of filings • Update for format, references, etc. • Flowcharts stay in • Open issues regarding software • May be separate, more specific software document • Staged rollout

12. Management Assessment • Overall management assessment of CDRH required by user fee agreement • Review of process - not substantive rules • FDA hired Booz Allan to conduct assessment • Booz Allan currently conducting assessment • Initial report in December 2013 • Final report May 2014 • Limited industry engagement to date • Implementation plans to follow

13. OC Reorganization • Recent OC announcement • Designed to focus attention and resources • Separate pre-market and post-market focus • Implications • More pre-market focus • Promotional review • Social media • Linkage to Case for Quality • Unclear how Caronia and 1st Amendment cases will impact CDRH labeling review

14. The Office of Compliance is reorganizing: From:

15. The Office of Compliance is reorganizing: To:

16. Comments from OC • Re-organization purpose • Align resources • Provide focus • Reflect priorities • Not an initiative to increase number of enforcement actions • Probable increase in labeling review • Note increased attention on international inspections and enforcement

17. Key Upcoming Guidances • Final guidances • 510(k) program (i.e. 510(k) paradigm) • Cyber security • Human factors • Companion diagnostics • De novo • Pivotal clinical trials (just issued) • Draft guidances • Risk benefit • Consensus standards • Other possible guidances (category B) • Interoperability • Accessories • Transfer of 510(k) ownership • Decision support software

18. Case for Quality • Major CDRH/OC initiative • Key aspects • Focus on improving quality • Aligning inspections with quality • Public metrics • Need industry engagement and specific actions • Linkages to inspection and enforcement processes • Part of TPLC • Multiple public meetings introducing Case for Quality

19. Shutdown Impact • CDRH was able to keep reviews going during shutdown • Access to user fees • Bolus of submissions “filed” same day • Need to work through the bolus • Assuming no additional shutdowns • CDRH says no measurable impact on MDUFA goals or review times • Some slowing of non-essential functions • Concern over additional sequestration and user fee trigger issues

20. Program Alignment Group (PAG) • Commissioner Hamburg initiative • Reassess current FDA organization • Reassess structure to look for synergies and overlaps • Potential reassessment of product centric approach • PAG members include center directors and other senior members of commissioner’s office • Results due in three months • Specialized inspectors • Technology linkages

21. Recall Assessments • FDASIA mandated report • Analyzing recalls • Report may come out in the next month • Overall methodology not yet public • Did review past recall patterns • Comparing recalls to administrations • Increased number of Class I recalls • 11 new internal classification SOPs • Reasons/trends being analyzed

22. Questions, Comments or Suggestions