FDA Outlines 2021 Guidance Priorities


November 5, 2020

Categories: AAMI News

The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has released its final and draft guidance publication priorities for the 2021 fiscal year. According to the FDA, the agency is committed to reviewing previously published final guidance documents and updating or deleting guidance documents no longer representing its current thinking on regulatory issues.

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.

CDRH is accepting feedback on the guidance documents on the three lists. Comments may be submitted electronically to www.regulations.gov docket FDA-2012-N-1021.


A-List

Final Guidance

  • Surgical Staplers

  • Safer Technologies Program for Medical Devices

  • Clinical Decision Support Software

  • Device-Specific Criteria Guidance(s) for Safety and Performance Based Pathway Implementation

  • Product Labeling for Laparoscopic Power Morcellators

Draft Guidance

  • Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act

  • Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order

  • Computer Software Assurance for Manufacturing and Quality System Software

  • Remanufacturing of Medical Devices

  • Case for Quality Voluntary Improvement Program

  • Device-Specific Criteria Guidance(s) for Safety and Performance Based Pathway Implementation

  • Transition Plan for Medical Devices Distributed Under Enforcement Policies or Emergency Use Authorization (EUA) During the COVID-19 Public Health Emergency

  • Content of Premarket Submissions for Management of Cybersecurity in Medical Devices

  • Unique Device Identification: Policy on Enforcement of GUDID Submission Requirements for Certain Class I Devices

  • Medical Device Shortages - Implementation of Section 506J of the Federal Food, Drug, and Cosmetic Act

  • Content of Premarket Submissions for Software Contained in Medical Devices

  • Electronic Submission Template for Premarket Notification (510(k)) Submissions

B-List

Final Guidance

  • Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation - Non-clinical Testing and Clinical Considerations

  • Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices

  • Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI)

  • Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment

  • Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations

Draft Guidance

  • Peroxide-Based Contact Lens Care Products – Patient Labeling Recommendations

  • Pre-Determined Change Control Plan: Premarket Submission Considerations for Artificial Intelligence and Machine Learning software

  • List of Highest Priority Devices for Human Factors Review

  • Clinical Considerations for Medical Device Premarket Submissions Targeting Opioid Use Disorder

  • Risk Categorization for Software as a Medical Device: FDA Interpretation, Policy and Considerations

Retrospective Review

1981

  • Investigational Medical Laser Significant Risk Device (Laser Notice 31)

  • Exemption from Reporting and Record keeping Requirements for Certain Sunlamp Product Manufacturers

1991

  • CPG Sec. 335.800 Clinical Thermometer - Adulteration; Misbranding Defects

  • Shelf Life of Medical Devices

  • Device Labeling Guidance #G91-1 (Blue Book Memo)

  • Quality Assurance Guidelines for Hemodialysis Devices

2001

  • Compliance Guidance: The Mammography Quality Standards Act Final Regulations: Preparing For MQSA Inspections; Final

  • Labeling Recommendations for Single-Use Devices Reprocessed by Third Parties and Hospitals: Final Guidance for Industry and FDA

  • Frequently-Asked-Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors: Final Guidance for Industry and FDA Staff

  • Information for Keratome Manufacturers Regarding LASIK - Final Guidance for Industry

  • Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff

  • Responsibilities of Laser Light Show Projector Manufacturers, Dealers, and Distributors; (Laser Notice 51)

  • Hospital Reprocessors: Guidance on Adverse Event Reporting for Hospitals that Reprocess Devices Intended by the Original Equipment Manufacturer for Single Use

  • Guidance on Medical Device Patient Labeling: Final Guidance for Industry and FDA Staff

  • Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Final Guidance for Industry and for CDRH Staff

  • Content of Investigational Device Exemptions for Solutions for Hypothermic Flushing, Transport and Storage of Organs for Transplantation - Guidance for Industry and FDA Reviewers

2011

  • Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses - Guidance for Industry and FDA Staff

  • Guidance for Industry and Food and Drug Administration Staff - Assembler's Guide to Diagnostic X-Ray Equipment

  • Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence - Guidance for Industry and FDA Staff

  • CPG Sec. 335.700 Surgeons' Gloves and Patient Examination Gloves; Defects - Criteria for Direct Reference Seizure