Recently, the United States Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) announced a list of priority guidance documents it plans to publish throughout this fiscal year (FY 2021). The list is separated into three categories: (1) an “A-list” of final and draft guidance documents the FDA intends to publish; (2) a “B-list” of final and draft guidance documents the FDA intends to publish as resources allow; and (3) a retrospective review list of final guidance documents that were issued in specific look-back years (2011, 2001, 1991, and 1981) for which the agency will conduct retrospective reviews.
The A-List
Topics included in the Final Guidance section of the “A-list’ include: Surgical Staplers; Safer Technologies Program for Medical Devices; Clinical Decision Support Software; Device-Specific Criteria Guidance(s) for Safety and Performance Based Pathway Implementation; and Product Labeling for Laparoscopic Power Morcellators.
Included on its A-list draft guidance agenda, FDA expects to publish documents related to the “Content of Premarket Submissions for Software Contained in Medical Devices,” which would serve to update the guidance document that industry has relied on since 2005. CDRH is also moving ahead with plans to issue guidance on “Electronic Submission Template for Premarket Notification (510(k)) Submissions” to follow its currently ongoing pilot program addressing electronic filing of premarket submissions in CDRH.
In addition, on the draft guidance topic list are: Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act; Procedures for Handling Post-Approval Studies Imposed by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 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; and Medical Device Shortages – Implementation of Section 506J of the Federal Food, Drug, and Cosmetic Act.
The B-List
On the B-List of final guidances that CDRH intends to publish as resources permit are the following topics: 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; and Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations.
Draft guidance topics CDRH is hoping to address in FY 2021 includes: 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; and Risk Categorization for Software as a Medical Device: FDA Interpretation, Policy and Considerations.
Retrospective Review List
When it comes to the retrospective reviews, CDRH is asking for suggestions on whether a final guidance should be revised or withdrawn. If a recommendation is made to revise or withdraw a guidance, commenters should include information regarding why it should be revised or withdrawn and, if it should be revised, how it should be revised.
The two Final Guidances from 1981 that CDRH is hoping to review are the Investigational Medical Laser Significant Risk Device (Laser Notice 31) and the Exemption from Reporting and Record keeping Requirements for Certain Sunlamp Product Manufacturers.
There are four Final Guidances from 1991 that CDRH expects to review: CPG Sec. 335.800 Clinical Thermometer – Adulteration; Misbranding Defects , Shelf Life of Medical Devices, Device Labeling Guidance #G91-1 (Blue Book Memo), and Quality Assurance Guidelines for Hemodialysis Devices.
Ten Final Guidances from 2001 will be reviewed by CDRH, including: 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, and Content of Investigational Device Exemptions for Solutions for Hypothermic Flushing, Transport and Storage of Organs for Transplantation – Guidance for Industry and FDA Reviewers.
2011 also brings four Final Guidances up for review, including: 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, and CPG Sec. 335.700 Surgeons’ Gloves and Patient Examination Gloves; Defects – Criteria for Direct Reference Seizure.
Comments Sought by CDRH
CDRH is looking for comments on the priority of documents, the draft language on the proposed topic list, reasons for the guidance, and proposed policy or information for the FDA to consider on the topic. CDRH is also open to receiving comments about new or different guidance document topics.