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
