What Guidance Documents Will CDRH Issue in 2017?

By MedTech Intelligence Staff

FDA prioritizes an A-list and B-list for the guidance documents it plans to publish in FY 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The A-list of draft guidance topics include IDE submissions, and new or revised procedural guidances for MDUFA IV implementation.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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