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FDA Medical Device Update

FDA Medical Device Update. US Food and Drug Administration New England District. Position at NWE-DO. Supervisory Investigator (May 2002) Monitor for Medical Device Program MDUFMA Coordinator. What is a Program Monitor?. Foods Imported cheese Domestic Fisheries Infant formula

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FDA Medical Device Update

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  1. FDA Medical Device Update US Food and Drug Administration New England District

  2. Position at NWE-DO • Supervisory Investigator (May 2002) • Monitor for Medical Device Program • MDUFMA Coordinator

  3. What is a Program Monitor?

  4. Foods Imported cheese Domestic Fisheries Infant formula Juice processing Pesticides …Many more Interstate Travel Dietary Supplements Blood banks Clinical Investigators Drug process inspections New Animal Drug inspections BSE (mad cow) Medical devices (Domestic and foreign) Mammography facilities Work for the District is in ~87 different program areas – examples:

  5. Program Monitoring • All 87 programs are split among the 7 supervisors. • Each has 12-14 programs for which s/he is the monitor

  6. Investigations Branch Staffing

  7. NWE-DO OEI

  8. Program monitor role • Identify the firms to be inspected or investigated • Verify that assignments are created • Assure the work is done and properly reported • Try to keep OEI up-to-date • Summarize accomplishments for management • Be the Point of Contact for that program

  9. Device Program – firm selection • CDRH guidance • Workplan • Budget • Staffing • Inspectional History

  10. CDRH Device Inspection Guidance • Inspect 20% of Registered Domestic Class II and Class III Medical Device Manufacturers, i.e., 1,030. (NWE-DO: 98) • Inspect 7% of Registered Foreign Class II and Class III Medical Device Manufacturers, i.e. 168 inspections. • Conduct CDRH BIMO Inspections, i.e., 278 inspections.

  11. CDRH Device Inspection Guidance • For Cause • MDUFMA – PMA/GMP inspections and other pre-market inspections including BIMO • Follow-Up to Violative Inspections • High/Significant Risk Class III and II Manufacturers • Special Emphasis • Focus on Firms with Repeated Violative Inspections • Focus on Risk-Based Center Initiated Inspection Assignments

  12. Risk-based Work Plan Initiative • CDRH “Call for Proposals”. The Call process incorporates involvement from both Center and Field sources focusing on risks, hazards, justified concerns, and output from various databases to achieve those devices and eventual individual manufacturers, which indicate need for Agency inspectional resources. • This is a directed inspection request with specific inspectional guidance in addition to GMP inspection.

  13. FY’07 Device Workplan

  14. NWE-DO Staff • Staff with devices as primary program = 12 • Staff with devices as second program = 9

  15. Training activities • 10 CSOs to Basic Medical Device • 2 CSOs to process validation • 1 CSO to industrial sterilization • 1 level II certification audit • 2 level II certified • 1 auditor certified • 1 AP auditor certified

  16. Pre-announcement of Inspection • Most inspections are pre-announced • NOT pre-announced: • f/u to Compliance action (W/L, etc.) • f/u to Complaint or informant • f/u to observe promised corrections (VAI)

  17. FY’06 District accomplishments

  18. FY’06 Compliance actions • 4 NWE-DO Medical Device firms had EI classified as OAI with Warning letter recommended • 3 Warning letters issued

  19. Summary of FY’06 Recalls • Total recalls in NWE-DO = 212 • Total CDRH recalls in NWE-DO = 145 • Class 1: 15 • Class 2: 116 • Class 3: 14

  20. Summary of Consumer Complaints (separate from MedWatch) • FY’05 - 13 Consumer Complaints regarding Medical Devices • 5 resulted in for-cause inspections • FY’06 - 13 Consumer Complaints regarding Medical Devices • 3 resulted in for-cause inspections

  21. Summary of for- cause InspectionsFY’05 +’06 • f/u to verify corrections - 15 • f/u to consumer complaint - 9 • Inside informants – 7 • Recall f/u – 8 • CDRH Risk Based assignment - 6 • f/u to violative EI @ another firm - 6 • f/u to injury report – 2 • Trade complaints – 2 • Shipment of products not approved for US mkt – 1 • Request of a State - 1

  22. Summary of 483s • 62/129 FY’06 device inspections had a 483 issued • i.e. in 48% of Medical Device inspections • vs. 47% of all product inspections in NWE-DO

  23. Other FY’06 NWE-DO Medical Device accomplishments • 3 Pre-Market Approval inspections • 7 Post-Market Audit inspections • 3 Non-clinical studies • 6 IRBs (2 U/L) • 5 Sponsor/Monitor/CRO (1 W/L) • 7 Clinical Investigators • 50 Mammography • 52 Import Field Exams

  24. Other FY’06 NWE-DO Medical Device accomplishments • 2 AP inspections including one level 3 audit • Candidate failed the audit, but then corrected and passed • 2 NWE-DO firms approved for use of third party inspectors under the AP program

  25. Contact Info • William S. Boivin • 781-596-7783 (phone) • 781-596-7896 (fax) • william.boivin@fda.gov

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