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

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

Contact Info

William S. Boivin 781-596-7783 (phone) 781-596-7896 (fax) [email protected]