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The A-list of draft guidance topics include IDE submissions, and new or revised procedural guidances for MDUFA IV implementation.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.