FDA-CDRH announced its plans, see UCM529396, for guidance document development in Fiscal Year 2017 (October 1, 2016 to September 30, 2017). The plan compromises lists, the A-List and the B-List. Each list also has a final guidance and a draft guidance component. The A-List is the prioritized medical device guidance documents FDA-CDRH intends to publish in FY 2017. The B-List is the guidance documents FDA-CDRH intends to publish, resources permitting.
A-List
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 guidance documents 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Draft Guidance Topics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 guidance documents for MDUFA IV implementation
B-List
Final Guidance Topics
- Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies
- Medical Device Development Tools (MDDT)
- FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions
- Unique Device Identification: Direct Marking of Devices
- Technical Considerations for Additive Manufactured Devices
Draft Guidance Topics
- Standard Content and Format for Patient Labeling of Medical Devices
- Standard Content and Format for Healthcare Provider Labeling of Medical Devices
- Patient Matched Instrumentation for Orthopedic Devices
- Utilizing Simulated Animal Transplant Models to Evaluate the Safety of Perfusion-based Organ Preservation Devices
- Strategy to Assess the Credibility of Computational Modeling Studies
- Related Replacement Reagent and Instrument Policy
- Unique Device Identification System: Defining the Labeler
- Considerations to Support a Claim of Electromagnetic Compatibility for Medical Electrical Equipment and Medical Electrical Systems