• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Medical Devices

  • Print
  • Share
  • E-mail

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.