U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. Device Advice: Comprehensive Regulatory Assistance
  4. Guidance Documents (Medical Devices and Radiation-Emitting Products)
  5. CDRH Proposed Guidances for Fiscal Year 2021 (FY 2021)
  1. Guidance Documents (Medical Devices and Radiation-Emitting Products)

CDRH Proposed Guidances for Fiscal Year 2021 (FY 2021)

The lists on this page include guidance documents that the FDA’s Center for Devices and Radiological Health (CDRH) intends to publish this fiscal year (FY 2021), as well as previously-issued final guidances for which CDRH was interested in receiving external feedback regarding whether these final guidances should be revised or withdrawn.

These lists are:

  • The A-list: A list of prioritized device guidance documents the FDA intends to publish during FY2021.
  • The B-list: A list of device guidance documents that the FDA intends to publish as resources permit during FY2021.
  • Retrospective review list: A list of final guidance documents issued in 1981, 1991, 2001, and 2011.

On this page:


A-List: Prioritized Guidance Documents that CDRH Intends to Publish in FY2021

Final Guidance Topics

  • 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Draft Guidance Topics

  • 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: Guidance Documents that CDRH Intends to Publish, as Guidance Development Resources Permit in FY2021

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

Draft Guidance Topics

  • 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 List of Guidances for 1981, 1991, 2001, and 2011

1981 Final Guidances

1991 Final Guidances

2001 Final Guidances

2011 Final Guidances


How to comment on these guidance lists or a specific guidance

CDRH would appreciate comments on any or all the guidance documents on the three lists. Specifically, CDRH is seeking comments on the relative priority of guidance documents. Comments could also include:

  • Draft language on the proposed A-list and B-list topics
  • Reasons the guidance is needed
  • Proposed policy or information for FDA to consider on the topic
  • Suggestions for new or different guidance documents. CDRH requests that stakeholders state the potential guidance topic in their comments.

For the retrospective review list, CDRH is seeking suggestions regarding which final guidances should be revised or withdrawn to help inform its retrospective review of existing final guidances. If a recommendation is made to withdraw or request a modification to an existing guidance document, CDRH requests that commenters also include information regarding why the guidance document should be revised or withdrawn and, if applicable, how it should be revised.

CDRH also welcomes any additional feedback for improving the guidance program and the quality of its guidance documents. CDRH believes this docket is an important tool for receiving information from interested parties and for making information available to the public. The feedback received is critical to the CDRH guidance program to ensure that stakeholder needs are met.

You may submit written comments to the Dockets Management Staff, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with docket number FDA-2012-N-1021 for "Notice to Public of Website Location of CDRH Fiscal Year 2021 Proposed Guidance Development."

Submit electronic comments to www.regulations.gov. Received comments will be placed in the docket and, except for those submitted as "Confidential Submissions," publicly viewable at www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. For more detailed information on submission of comments, please refer to the Federal Register notice entitled "Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal Year 2021 Proposed Guidance Development."

 

Back to Top