2020 Guidance: CDRH Offers a Look at What’s Coming

Regulatory NewsRegulatory News | 11 October 2019 |  By 

FDA’s Center for Devices and Radiological Health (CDRH) on Friday released its FY 2020 draft and final guidance list, which features a few repeats from last year and new drafts coming on device servicing and remanufacturing, unique device identification and patient-reported outcome measures used in device submissions, among others.

As in years past, CDRH divides the list between “A-list” draft and final guidances, which are a priority, and a smaller “B-list” of draft and final guidances, which CDRH says it will publish as resources permit.

In addition to the aforementioned A-list draft guidances, CDRH also plans to publish one on labeling for breast implants, one on implementing its new Safety and Performance Based Pathway and two revised draft guidances on post-market surveillance and post-approval studies.

There are also repeats from last year’s draft guidance A-list, such as one on the “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” and one on “Computer Software Assurance for Manufacturing, Operations, and Quality System Software.”

A-list final guidance topics include: The B-list final guidance documents that may be published include:
  • Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use
  • Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use
  • Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices
  • Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI)
And the B-list draft guidance documents include:
  • Point-of-Care Prothrombin Time/International Normalized Ratio Monitoring Systems for Professional Use and Prescription Self-Monitoring Use
  • Risk Categorization for Software as a Medical Device: FDA Interpretation, Policy and Considerations
CDRH Proposed Guidances for Fiscal Year 2020 (FY 2020)


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