What Guidance Documents Will CDRH Issue in 2017?
FDA has updated its latest list of final guidances that are a priority for FY 2017. The A-list includes the guidances that FDA fully intends to publish, and the B-list contains guidance documents that the agency will publish resource permitting.
The A-list of final guidances includes:
- Postmarket Management of Cybersecurity in Medical Devices
- Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices
- Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS) – Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases
- Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
- Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers
The A-list of draft guidance topics include IDE submissions, and new or revised procedural guidances for MDUFA IV implementation.
FDA’s B-list of final guidance documents include:
- UDI: Direct Marking of Devices
- Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies
- FDA Categorization of IDE Devices to Assist the CMS with Coverage Decisions
The B-list of draft guidances includes:
- Patient Matched Instrumentation for Orthopedic Devices
- Utilizing Simulated Animal Transplant Models to Evaluate the Safety of Perfusion-based Organ Preservation Devices
- UDI System: Defining the Labeler
A full list is available on FDA’s website.
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