FDA’s 510(k) Third-Party Review Program

1. FDA’s 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