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Device Initiatives FY 2005

Device Initiatives FY 2005. Karen A. Coleman FDA Device National Expert. Device Initiative Topics. Accredited Persons Inspection Program Device Certification Program Enforcement Initiatives Recalls Warning Letters, Untitled letters, FY ’04 Actions GMP / 483’s

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Device Initiatives FY 2005

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  1. Device InitiativesFY 2005 Karen A. Coleman FDA Device National Expert

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

  3. ACCREDIATED PERSONS AUDIT PROGRAM

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

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

  6. Accredited Persons Audit Program • 2 AP’s have 2 out of 3 performance audits • 20 AP’s need the 3 performance audits • 6 people no longer participate

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

  8. Device Certification

  9. Device Certification • Certified Device Investigators = 55 • Total certified since implementation • 130 • Device Auditors = 37

  10. Device Certification • Device Certification Work Programs • Domestic Audits • MRA’s • AP

  11. ENFORCEMENT INITIATIVES RECALLS FDA

  12. Recall Actions FY 2001

  13. Recall Actions FY 2002

  14. Recall Actions FY 2003

  15. Recall Actions FY 2004

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

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

  18. ENFORCEMENT INITIATIVES WARNING LETTERS UNTITLED LETTERS FY’04 ACTIONS

  19. FY 2004 Warning Letters = 218

  20. FY 2004 Untitled Letters = 108

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

  22. ENFORCEMENT INITIATIVES GMP /483 Citation TOP TEN

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

  24. 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 …..

  25. GMP / 483 Top Ten • 820.100(b) Corrective and preventive action activities have not been documented including ………………… • 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…………………..

  26. 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] …........................................

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

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

  29. THE GOOD THE BAD THE UGLY

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