FDA Outlines 2020 Guidance Priorities


Posted October 15, 2019

The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has released its final and draft guidance publication priorities for the 2020 fiscal year. This year’s announcement comes days after President Donald Trump issued a pair of executive orders aimed at curtailing enforcement actions through guidance documents.

CDRH’s guidance publication priorities cover a variety of new topics, including Multiple Function Device Products: Policy and Considerations and the Accreditation Scheme for Conformity Assessment Pilot Program. Repeats from FY2019 include Content of Premarket Submissions for Management of Cybersecurity in Medical Devices and Computer Software Assurance for Manufacturing, Operations, and Quality System Software.

The proposed guidance documents are organized into an "A-list" that the agency fully intends to publish a "B-list" that the agency intends to publish as resources permit, and a list of final guidance documents published subject to focused retrospective review.

A-List

Final Guidance Topics

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

Draft Guidance Topics

  • Labeling and Informed Decision Checklist for Breast Implants
  • Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
  • Distinguishing between Medical Device Servicing and Remanufacturing
  • Computer Software Assurance for Manufacturing, Operations, and Quality System Software
  • Procedures for Handling Post-Approval Studies Imposed by PMA Order (revision)
  • Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act (revision)
  • Unique Device Identification: Policy on Enforcement of GUDID Submission Requirements for Certain Class I Devices
  • Pragmatic Generation of Validity Evidence for Patient-Reported Outcome Measures Used in Medical Device Submissions
  • Device-Specific Criteria Guidance(s) for Safety and Performance Based Pathway Implementation

B-List

Final Guidance Topics

  • 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)

Draft Guidance Topics

  • 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’s annual list of guidance priorities comes at a time of heightened scrutiny from the White House regarding the use of guidance documents by federal agencies. Two executive orders by President Trump earlier this month require the Office of Information and Regulatory Affairs to review significant guidance documents before they are issued and calls for federal agencies to more prominently state that guidance documents are not legally binding. The orders also call for the creation of procedures for petitioning for the removal or modification of guidance documents, among other provisions.

“When an agency takes an administrative enforcement action, engages in adjudication, or otherwise makes a determination that has legal consequence for a person, it must establish a violation of law by applying statutes or regulations,” one of the executive orders reads. “The agency may not treat noncompliance with a standard of conduct announced solely in a guidance document as itself a violation of applicable statutes or regulations.”

The FDA is seeking feedback from the public on the priority of topics for guidance and any other feedback that could benefit the guidance program and its engagement with stakeholders at www.regulations.gov until Dec. 16 (docket number FDA-DRDOC-0001-9587).