FDA Guidance​ Documents

The US FDA has produced the A-List of Guidance Documents that CDRH intends to publish in FY2020. 

A-List: Prioritized Guidance Documents for FY2020 

Final Guidance Topics

  • Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices
  • Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments Waiver by Application Studies
  • 510(k) Third Party Review Program
  • Safer Technologies Program for Medical Devices
  • Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices
  • Labeling Recommendations for Surgical Staplers
  • Nonbinding Feedback After Certain Food and Drug Administration Inspections of Device Establishments
  • The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program
  • Recognition and Withdrawal of Voluntary Consensus Standards
  • Clinical Decision Support Software
  • Multiple Function Device Products: Policy and Considerations
  • Device-Specific Criteria Guidance(s) for Safety and Performance Based Pathway Implementation

Leave a Reply

Your email address will not be published. Required fields are marked *