Embed Size (px)
Citation preview
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?
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
Program Monitoring
All 87 programs are split among the 7 supervisors.
Each has 12-14 programs for which s/he is the monitor
Investigations Branch Staffing
Position 2006 2004
Consumer Safety Officers 64 85
Consumer Safety Inspectors 7 7
Supervisory CSOs 7 8
NWE-DO OEI
12/2006 12/2004
Total firms 8857 8365
Device firms 3004 2781
Class II and III firms 556 535
New England District Domestic Inventory
CBER3%
CDER12%
CVM2%
CFSAN48%
CDRH35%
CFSAN
CBER
CDER
CVM
CDRH
~50% of 8857 firms are food firms
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
Device Program – firm selection
CDRH guidance Workplan
– Budget– Staffing
Inspectional History
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.
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
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.
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 7 ---
Foreign 15 17
AP 2 9
TOTAL 141 180
NWE-DO Staff
Staff with devices as primary program = 12 Staff with devices as second program = 9
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
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)
FY’06 District accomplishments
QS/GMP Inspectional Accomplishments
Domestic Foreign Total
# OPS Planned
129 15 144
# OPS Accomplished
146 14 160
FY’06 Compliance actions
4 NWE-DO Medical Device firms had EI classified as OAI with Warning letter recommended– 3 Warning letters issued
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
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
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
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
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
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 FY’06 NWE-DO Medical Device accomplishments
