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

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Presentation on theme: "FDA Medical Device Update US Food and Drug Administration New England District."— Presentation transcript:

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 Work for the District is in ~87 different program areas – examples: 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

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

6 Investigations Branch Staffing Position Consumer Safety Officers6485 Consumer Safety Inspectors77 Supervisory CSOs78

7 NWE-DO OEI 12/200612/2004 Total firms Device firms Class II and III firms556535


9 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

10 Device Program – firm selection CDRH guidance Workplan – Budget – Staffing Inspectional History

11 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.

12 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

13 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.

14 FY07 Device Workplan FY2007FY2006 Level I6584 Level II4353 Compliance f/u28 For Cause79 High Risk Domestic7--- Foreign1517 AP29 TOTAL141180

15 NWE-DO Staff Staff with devices as primary program = 12 Staff with devices as second program = 9

16 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

17 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)

18 FY06 District accomplishments QS/GMP Inspectional Accomplishments DomesticForeignTotal # OPS Planned # OPS Accomplished

19 FY06 Compliance actions 4 NWE-DO Medical Device firms had EI classified as OAI with Warning letter recommended – 3 Warning letters issued

20 Summary of FY06 Recalls Total recalls in NWE-DO = 212 Total CDRH recalls in NWE-DO = 145 – Class 1: 15 – Class 2: 116 – Class 3: 14

21 Summary of Consumer Complaints (separate from MedWatch) FY Consumer Complaints regarding Medical Devices – 5 resulted in for-cause inspections FY Consumer Complaints regarding Medical Devices – 3 resulted in for-cause inspections

22 Summary of for- cause Inspections FY 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 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

23 Summary of 483s 62/129 FY06 device inspections had a 483 issued – i.e. in 48% of Medical Device inspections – vs. 47% of all product inspections in NWE-DO

24 Other FY06 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

25 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 Other FY06 NWE-DO Medical Device accomplishments

26 Contact Info William S. Boivin (phone) (fax)

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