Transcript Medical Device Update

FDA Medical Device Update
US Food and Drug
Administration New
England District
Position at NWE-DO
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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:
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Foods
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Imported cheese
Domestic Fisheries
Infant formula
Juice processing
Pesticides
…Many more
Interstate Travel
Dietary Supplements
Blood banks
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Clinical Investigators
Drug process
inspections
New Animal Drug
inspections
BSE (mad cow)
Medical devices
(Domestic and foreign)
Mammography facilities
Program Monitoring
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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
CFSAN
CBER
CDER
CBER
3%
CDER
12%
CVM
2%
CVM
CDRH
CFSAN
48%
CDRH
35%
~50% of 8857 firms are food firms
Program monitor role
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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
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CDRH guidance
Workplan
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Budget
Staffing
Inspectional History
CDRH Device Inspection Guidance
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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
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For Cause
MDUFMA – PMA/GMP inspections and other premarket inspections including BIMO
Follow-Up to Violative Inspections
High/Significant Risk Class III and II Manufacturers
Special Emphasis
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Focus on Firms with Repeated Violative Inspections
Focus on Risk-Based Center Initiated Inspection
Assignments
Risk-based Work Plan Initiative
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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
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Foreign
15
17
AP
2
9
141
180
TOTAL
NWE-DO Staff
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Staff with devices as primary program = 12
Staff with devices as second program = 9
Training activities
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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
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Most inspections are pre-announced
NOT pre-announced:
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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
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4 NWE-DO Medical Device firms had EI
classified as OAI with Warning letter
recommended
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3 Warning letters issued
Summary of FY’06 Recalls
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Total recalls in NWE-DO = 212
Total CDRH recalls in NWE-DO = 145
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Class 1: 15
Class 2: 116
Class 3: 14
Summary of Consumer Complaints
(separate from MedWatch)
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FY’05 - 13 Consumer Complaints regarding
Medical Devices
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5 resulted in for-cause inspections
FY’06 - 13 Consumer Complaints regarding
Medical Devices
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3 resulted in for-cause inspections
Summary of for- cause Inspections
FY’05 +’06
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f/u to verify corrections - 15
f/u to consumer complaint - 9
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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
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62/129 FY’06 device inspections had a 483
issued
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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
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3
7
3
6
5
7
50
52
Pre-Market Approval inspections
Post-Market Audit inspections
Non-clinical studies
IRBs (2 U/L)
Sponsor/Monitor/CRO (1 W/L)
Clinical Investigators
Mammography
Import Field Exams
Other FY’06 NWE-DO Medical Device
accomplishments
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2 AP inspections including one level 3 audit
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Candidate failed the audit, but then corrected and
passed
2 NWE-DO firms approved for use of third
party inspectors under the AP program
Contact Info
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William S. Boivin
781-596-7783 (phone)
781-596-7896 (fax)
[email protected]