FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH

What is Third Party review?

• Description
• Expansion pilot
• Advantages to using this program

How to use this program

• Four basic steps
• List of Accredited persons

Devices for Third Party review

• How to use the list of eligible devices
• Some important exceptions to the list
• Expansion pilot
• List of devices

Guidance and Documents

• Guidance for Third Parties and FDA Staff - Third Party Review of Premarket Notifications
• Implementation of Third Party Programs
  • Appendix A - Qualification Standards for FDA Reviewers
  • Appendix B- Standards of Ethical Conduct for Employees of the Executive Branch
  • FR Notice of Availability, March 8, 2001
• Inclusion of Certain Devices Within the Accredited Persons Program - Third Party Review of Clinical Data - A Report to Congress