Premarket Notification: Analysis of FDA Recall Data

Size: px

Start display at page:

Download "Premarket Notification: Analysis of FDA Recall Data"

Erik Reed
6 years ago
Views:

1 Premarket Notification: Analysis of FDA Recall Data Director, Medical Device Safety Institute Beth Israel Deaconess Medical Center Boston, MA IOM 510(k) Workshop July 28, 2010

2 Disclosure FDA Consultant

3 Overview Background Overview of FDA 510(k) and Recall Databases Data Analysis Conclusions

4 Device Approval/Clearance Performance Measures IDEAL Device Reliability, Device Performance SURROGATE Regulatory Actions Recalls Medical Device Reports (MDRs) Other (Warning Letters, etc)

5 FDA Recall Definition A recall is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. -U.S. Food and Drug Administration

6 Purpose of this Study Analyze FDA recall data affecting 510(k) products Provide estimate of 510(k) product recall rates Describe causes of recalls affecting 510(k) products Identify product risk factors for recall

7 Data Analysis 1996 FDA 510(k) Database FDA Recall 2009 Database

8 Annual # 510(k) Applications Total = 48,402 Range =

9 Advisory Committee Assignments for 510(k)s Submitted (k)s % ANCH CV DE EN GU HE HO IM MI NE OB OP OR PA PM RA SU TX

10 510(k) Device Classification %

11 510(k) Type % of Applications

12 510(k) Type

13 510(k) Features

14 Annual Number of Unique 510(k)s Affected by Recall

15 Number of Recalls per 510(k) Recalls per 510(k) # Occurrences Percentage of 510(k) Recalls >

16 Year of 510(k) Decision for Recalls Occurring %

17 Determining Recall Rate Accounting for Differential Follow-Up A B C D E Recall Recall Study End Study End Study End F Recall 01/01/03 12/31/09

18 Recall-Free 510(k) Survival Proportion Recall-Free YEARS SINCE 510(k) DECISION # at Risk: Survival:

19 Annual 510(k) Recall Rate Based on Years Since Decision Percent Recalled YEARS SINCE 510(k) DECISION

20 Causes of 510(k) Recalls Cause Description Recalls (%) Manufacturing Process Device Design Materials/ Components Change Control Employee Error Manufacturing process inadequately controlled, inadequate environmental controls, storage, packaging, labeling, equipment maintenance, material removal, etc. Failure of device to perform as intended despite meeting design specifications. Materials/components that are non-conforming, contaminated, degraded, counterfeit or inadequately tested. A change made to a specification, program, procedure, vendor, etc. that adversely affects a component, finished device, packaging, labeling, etc. Employee error (not a systematic problem). Usually corrected by retraining. Miscellaneous TOTAL

21 Number of Predicates 510(k) P for trend = 0.003

22 Number of Predicates 510(k) P for trend < AGE OLDEST PREDICATE

23 510(k) Type * P< % of Applications *

24 510(k) Features * * P<0.001 * * Review Office

25 510(k) Features * P<0.001 *

26 510(k) Device Classification % * P<0.001 * *

27 Advisory Committee Assignments for 510(k)s Submitted % No Recall Recall % AN CH CV DE EN GU HE HO IM MI NE OB OP OR PM RA SU TX

28 Medical Device Reporting and 510(k)s Description Number 510(k)s with MDR 7823 Total MDRs MDRs with Death 2361 MDRs with Injury MDRs with Malfunction MDRs Other 5051

29 Medical Device Reporting and Recalls

30 Summary of Key Findings 1. More than 3000 devices are cleared for marketing each year under new 510(k)s. Overall, there have been more than 48, (k)s since Recalls affect 510(k) devices times annually. 3. The annual rate of recall for 510(k) products is ~ % per year for the first 4 years post clearance; the rate falls to ~ 1.0% for postmarket years Manufacturing process and device design issues are the most common causes cited for 510(k) recalls. 5. A large number of predicates, special 510(k)s, 3 rd party reviews, and life-sustaining devices are associated with a higher rate of recall.

31 Acknowledgments FDA Ann Ferriter Shawn Forrest Eugene Reilly Gerry Gray IOM Heather Colvin Abigail Mitchell

Using Recall Data to Assess the 510(k) Process

Using Recall Data to Assess the 510(k) Process Ralph F. Hall Distinguished Professor and Practitioner University of Minnesota Law School July 28, 2010 Acknowledgments 2 Disclosures 3 Agenda I. Research