CDRH is setting its goals along with the rest of us for the new year. The agency has published and prioritized its intentions for FY2017, starting with a list of new documents it intends to release in FY2017 (A-list). It has also shared a B-list of previously-issued final guidances for which CDRH would like feedback, as well as a list of documents from 2007, 1997, 1987, and 1977 that it will retrospectively review. As always, these goals are subject to budgets and time. CDRH plans to update all three lists every year as part of FDA’s agreement made during negotiations for MDUFA III in 2012.
Stakeholder needs are at CDRH’s top of mind, and the agency is asking comments on further prioritizing, suggestions for new or different documents, as well as comments on why certain guidances might be needed. CDRH is also asking for feedback on whether any of these should be revised or withdrawn.
The A-list topics are as follows:
Final Guidance Topics
• Postmarket Management of Cybersecurity in Medical Devices
• Medical Device Accessories: Describing Accessories and Classification Pathway for New Accessory Types
• Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices
• Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions
• Suggested Format for Developing and Responding to Deficiencies
• Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics
• Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS) – Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases
• Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS) – Based In Vitro Diagnostics
• Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers
• Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
• 510(k) Third Party Review Program
• New or revised procedural guidances for MDUFA IV implementation
Draft Guidance Topics
• IDE Submission, Content, Organization, Interactions
• Update to Section V Demonstrating Insignificant Risk of an Erroneous Result in the Recommendations: Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices guidance
• Dual 510(k) and CLIA Waiver
• New or revised procedural guidances for MDUFA IV implementation
The B-list and the retrospective list can be found on CDRH’s site along with relevant links and instructions on how to comment.
