2. Device Initiatives FY 2005 Karen A. Coleman FDA Device National Expert

3. Device Initiative Topics Accredited Persons Inspection Program Accredited Persons Inspection Program Device Certification Program Device Certification Program Enforcement Initiatives Enforcement Initiatives Recalls Recalls Warning Letters, Untitled letters, FY 04 Actions Warning Letters, Untitled letters, FY 04 Actions GMP / 483s GMP / 483s Single Use Devices [SUD] Reprocessed by Third Parties and Hospitals Single Use Devices [SUD] Reprocessed by Third Parties and Hospitals

4. ACCREDIATED PERSONS AUDIT PROGRAM

5. Accredited Persons [AP] Audit Program Key Dates 10/26/02 – MDUFMA signed into law 10/25/03 – Top 15 APs listed 1/12/04 – FDA AP Training 1/12/04 – FDA AP Training 04/28/04 – New AP applications accepted 04/28/04 – New AP applications accepted 05/2005 – Possible date next FDA Training

6. Accredited Persons Audit Program 8 APs completed 3 performance audits for MRA and meet AP requirements. 8 APs completed 3 performance audits for MRA and meet AP requirements. May conduct independent audits for FDA May conduct independent audits for FDA 4 APs completed 1 or 2 performance audits under MRA. Additional requirements needed. 4 APs completed 1 or 2 performance audits under MRA. Additional requirements needed. 19 APs completed1 out of 3 performance audits 19 APs completed1 out of 3 performance audits

7. Accredited Persons Audit Program 2 APs have 2 out of 3 performance audits 2 APs have 2 out of 3 performance audits 20 APs need the 3 performance audits 20 APs need the 3 performance audits 6 people no longer participate 6 people no longer participate

8. Accredited Persons Web References http://www.fda.gov/cdrh/ap-inspection/ap- inspection.html http://www.fda.gov/cdrh/ap-inspection/ap- inspection.html http://www.fda.gov/cdrh/ap-inspection/ap- inspection.html http://www.fda.gov/cdrh/ap-inspection/ap- inspection.html http://www.fda.gov/cdrh/thirdparty/thirdparty- how.html http://www.fda.gov/cdrh/thirdparty/thirdparty- how.html http://www.fda.gov/cdrh/thirdparty/thirdparty- how.html http://www.fda.gov/cdrh/thirdparty/thirdparty- how.html http://www.fda.gov/cdrh/mdufma/aprating.ht ml http://www.fda.gov/cdrh/mdufma/aprating.ht ml http://www.fda.gov/cdrh/mdufma/aprating.ht ml http://www.fda.gov/cdrh/mdufma/aprating.ht ml http://www.fda.gov/cdrh/mdufuma/guidance/ 1200/html http://www.fda.gov/cdrh/mdufuma/guidance/ 1200/html

9. Device Certification

10. Certified Device Investigators = 55 Certified Device Investigators = 55 Total certified since implementation Total certified since implementation 130 130 Device Auditors = 37 Device Auditors = 37

11. Device Certification Device Certification Work Programs Device Certification Work Programs Domestic Audits Domestic Audits MRAs MRAs AP AP

12. ENFORCEMENT INITIATIVES RECALLS FDAFDA

13. Recall Actions FY 2001

14. Recall Actions FY 2002

15. Recall Actions FY 2003

16. Recall Actions FY 2004

18. Device Packaging Recalls 04 22 Recalls due to Packaging Failures 22 Recalls due to Packaging Failures Cause by 3 Failure Modes Cause by 3 Failure Modes Packaging Design/ Selection [10] Packaging Design/ Selection [10] Packaging Change Control [1] Packaging Change Control [1] Packaging Process Control [11] Packaging Process Control [11]

19. Device Labeling Recalls 04 59 Recalls due to labeling failures 59 Recalls due to labeling failures Caused by 4 failure modes Caused by 4 failure modes Labeling Mix-ups/Errors [15] Labeling Mix-ups/Errors [15] Labeling Design [3] Labeling Design [3] Labeling Change Control [10] Labeling Change Control [10] Labeling False and Misleading [31] Labeling False and Misleading [31]

20. ENFORCEMENT INITIATIVES WARNING LETTERS UNTITLED LETTERS FY04 ACTIONS

21. FY 2004 Warning Letters = 218

22. FY 2004 Untitled Letters = 108

23. FY 2004 Device Legal Actions 2 Seizures 2 Seizures 2 Injunction Recommendations 2 Injunction Recommendations 1 filed 1 filed 1 in litigation 1 in litigation 2 Civil Money Penalties 2 Civil Money Penalties

24. ENFORCEMENT INITIATIVES GMP /483 Citation TOP TEN

25. GMP / 483 Top Ten 1. 820.198 Complaint handling procedures for [rec.] [reviewing] [eval.] complaints have not been [est.] [defined] [doc.] [completed] [implemented]………. 2. 820.100(a) Procedures for implementing corrective and preventive actions were not [est.] [defined] [doc.] [complete] [implemented ] ……….

26. GMP / 483 Top Ten 3.803.17 Written MDR procedures have not been [developed] [maintained] [implemented]…………… 4.820.22 Quality Audits were not conducted [at sufficient regular intervals, as prescribed by internal procedures] to verify that the quality system is effective in fulfilling your quality system objectives …..

27. GMP / 483 Top Ten 5. 820.100(b) Corrective and preventive action activities have not been documented including ………………… 6. 820.75(a) A process whose results cannot be fully verified by subsequent inspection and test has not been [adequately] [fully] validated and approved according to established procedures…………………..

28. GMP / 483 Top Ten 7.820.20 Management with executive responsibility has not ensured that an adequate and effective quality system has been fully implemented and maintained at all levels of the organization………………. 8.820.22 Procedures for conducting quality audits were not [estab.] [defined] [doc.] [complete] …........................................

29. GMP / 483 Top Ten 9. 820.30(i) Procedures were not [est.] [defined] [doc.] …..for the [id.] [doc.] [validation or verification] [review] [approval] of design changes before their implementation………………………. 10. 820.30(a) Procedures to control the design process of the devices were not [est.] [defined] [doc.] [complete] [implemented]………………..

30. ENFORCEMENT ISSUE – SUDs Reuse of Single Use Devices (SUDs) Reuse of Single Use Devices (SUDs) i.e. reprocessed by third parties and hospitals i.e. reprocessed by third parties and hospitals All reprocessors have premarket approval requirements unless exempted by regulation. All reprocessors have premarket approval requirements unless exempted by regulation. All firms were inspected All firms were inspected Significant GMP deficiencies noted for many Significant GMP deficiencies noted for many Primarily validation and component control Primarily validation and component control 17 Warning Letters were issued 17 Warning Letters were issued 2 Injunctions were imposed 2 Injunctions were imposed www.fda.gov/cdrh/reuse/index.html www.fda.gov/cdrh/reuse/index.html

31. THE GOOD THE BAD THE UGLY