Presentation: 510(k) Third Party Reviews

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Eric Rechen
Policy Analyst Program Operations Staff
FDA Office of Device Evaluation
CDRH
 

Third Party Review Program(a.k.a. “Accredited Persons Program”)

• Gives 510(k) submitters the option of using accredited, non-Federal organizations to review 510(k)s for low and moderate risk devices, in place of FDA’s review
• Authorized by §523 of the FD&C Act
   

Purpose

• More rapid decisions
• Better allocationof FDA’s resources

Comparison of Average Total Elapsed Days for 510(k) Reviews- Excluding “Special” 510(k)s -(FY 2005 Receipts)

Use of Third Parties

• Approximately 300 “third party” 510(k)s in FY 2008
• 8% of all 510(k)s
   

How Does It Work?

Third Party (TP) Review Process

• Applicant may elect to use TP or FDA for eligible devices
   
• If TP route is chosen:
  Applicant contracts with TP
  
  • TP reviews 510(k), makes recom.
     
  • FDA issues final decision (30 days)

FDA’s Third Party Web Page 

Procedural guidance

• List of eligible devices
• List of Accredited Persons

Which Devices Are Eligible?

Eligible Devices

• More than 670 eligible Class I and Class II device types
• 60% of all 510(k) submissions
• Eligible device list
   

Statutory Limitation§ 523(a)(3)

Third parties 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

Statutory Limitation§ 523(a)(3)

Third parties also may not review:

• 510(k)s that require CBER/CDER lead or consulting review. Example:
  (e.g., drug/device combination products)
  

Who Are the Third Parties?

Accredited Organizations

• British Standards Institution (United Kingdom)
• Center for Measurement Standards, ITRI (Taiwan)
• Cheiroon, BV (Netherlands)
• CITECH
• Intertek Testing Services
• KEMA Quality, BV (Netherlands)
• NIOM Scand. Inst. of Dental Materials (Norway)
• Regulatory Technology Services, LLC
• TUV SUD America, Inc.
• TUV Rheinland of North America, Inc.
• Underwriters Laboratories, Inc.

Accreditation of Third Parties

• FDA serves as accreditation body
   
• Emphasis is on adequacy of:
• Personnel and procedures to ensure competent reviews
  • Controls to prevent conflict of interest

Why Consider a Third Party?

• Usually more timely
• Many TPs also have standards expertise and foreign regulatory role
• Accessibility
• No FDA user fee

When to Think Twice

• Complex, precedent-setting submissions
• Device eligibility uncertain
  (e.g., may require clinical data)
• “Special” 510(k)s
• TP lacks relevant experience

Questions?

• FDA’s third party web page
• CDRHLearn@fda.hhs.gov
• Eric Rechen, ODE/CDRH:
  301-796-6562
  eric.rechen@fda.hhs.gov
• 510(k) Staff, ODE/CDRH
  301-796-5640
• DSMICA 800-638-2041
  dsmica@fda.hhs.gov