Sources of General Premarket Notification 510(k) Guidance for Third Party Review

General FDA guidance relevant to the preparation and review of Premarket Notifications 510(k)'s is provided below.  Accredited Persons or Conformity Assessment Bodies (CABs) under the Third Party Program should refer to this guidance when reviewing eligible devices for which device-specific guidance does not exist.  Device-specific guidance and/or FDA recognized standards are available for Accredited Persons and CABs to use when reviewing many eligible devices. 

• Guidance for Third Parties and FDA Staff: Third Party Review of Premarket Notifications (September 28, 2004)

• Device Advice: Premarket Notification 510(k)

• Device-specific guidance and additional general guidance (for particular medical specialty areas or cross-cutting issues) can be found on the Guidance Documents page.

• FDA recognized standards can be found at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.  

• In Vitro Diagnostic Devices: Guidance for the Preparation of 510(k) Submissions (January 1997) HHS Pub. FDA 97-4224

• Releasable Premarket Notification 510(k) Database  

• Device Classification Database