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

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There are also repeats from last year’s draft guidance A-list, such as one on the “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” and one on “Computer Software Assurance for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

• Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices, which was first drafted in 2017
• Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments Waiver by Application Studies, first drafted in 2017
• 510(k) Third Party Review Program, drafted in September 2018
• Safer Technologies Program for Medical Devices, drafted in September 2019
• Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices, drafted in August 2018
• Labeling Recommendations for Surgical Staplers, drafted in April 2019
• Nonbinding Feedback After Certain Food and Drug Administration Inspections of Device Establishments, drafted in February 2019
• The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program, drafted in September 2019
• Recognition and Withdrawal of Voluntary Consensus Standards, drafted in September 2018
• Clinical Decision Support Software, following a draft from December 2017
• Multiple Function Device Products: Policy and Considerations, drafted in April 2018
• Device-Specific Criteria Guidance(s) for Safety and Performance Based Pathway Implementation

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)