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
2006
2004
Consumer Safety Officers 64 85
Consumer Safety Inspectors 7
Supervisory CSOs 8

7. NWE-DO OEI 12/2006 12/2004 Total firms 8857 8365 Device firms 3004
2781
Class II and III firms
556
535

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. FY’07 Device Workplan FY2007 FY2006 Level I 65 84 Level II 43 53
Compliance f/u 2 8
For Cause 7 9
High Risk Domestic
---
Foreign 15 17 AP
TOTAL
141
180

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. FY’06 District accomplishments
QS/GMP Inspectional Accomplishments
Domestic
Foreign
Total
# OPS Planned
129 15
144
# OPS Accomplished
146 14
160

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

20. 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

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’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 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 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

24. 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

25. 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

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