FDA

1
FDAs 510(k) Third-Party Review Program

• Blood Products Advisory
• Committee Meeting
• Gaithersburg, MD
• September 15, 2000
• Eric J. Rechen
• Office of Device Evaluation
• CDRH, FDA

2
Purpose of Program

• Provide an alternative 510(k) review process that
  can yield more rapid marketing clearance
  decisions
• Enable FDA to target its resources at higher-risk
  devices

3
Origin

• 1996 - FDA began 2-year pilot
• 1997 - FDAMA enacted established
• 523 Accredited Persons
• 1998 - AP program implemented
• http//www.fda.gov/cdrh/thirdparty

4
Main Features

• FDA accredits third parties (APs)
• Mfr. may elect to use AP or FDA
• If AP route is chosen
• Mfr. contracts for review, sends 510(k) to AP
• AP reviews 510(k), makes recommendation to FDA
• FDA issues final decision (30 days)

5
Accredited Organizations

• British Standards Institution (United Kingdom)
• California Department of Health Services
• Center for Measurement Standards, ITRI (Taiwan)
• Cheiroon BV (Netherlands)
• CITECH
• Entela, Inc.
• Intertek Testing Services
• NIOM Scand. Inst. of Dental Materials (Norway)
• N.V. Kema (Netherlands)
• TUV Product Service
• TUV Rheinland of North America, Inc.
• Underwriters Laboratories, Inc.

6
Devices - Statutory Criteria

• Accredited Persons may not review
• Class III devices
• Class II devices that
• are permanently implantable
• are life sustaining/supporting, or
• require clinical data in 510(k)s

7
List of Eligible Devices

• Current list includes 211 devices
• 57 Class I devices
• 154 Class II devices
• More than 1,600 eligible 510(k)s/year
• Expansion pilot recently proposed
• Devices reviewed by CBER/CDER not included at
  this time

8
Program Experience

• Industry participation low, but growing
• Good quality reviews
• More rapid 510(k) clearance