The lists on this page include guidance documents the FDA’s Center for Devices and Radiological Health (CDRH) intends to publish this fiscal year (FY2022), as well as previously-issued final guidances for which CDRH is interested in receiving external feedback regarding whether these guidances should be revised or withdrawn.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 FY2022.
- The B-list: A list of device guidance documents the FDA intends to publish as resources permit during FY2022.
- Retrospective review list: A list of final guidance documents issued in 1982, 1992, 2002, and 2012.
On this page:
Final Guidance Topics
- Clinical Decision Support Software
- 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
- Remanufacturing of Medical Devices
- Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices
- Electronic Submission Template for Premarket Notification (510(k)) Submissions
Draft Guidance Topics
- Computer Software Assurance for Production and Quality System Software
- Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program
- Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
- Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
- Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
- Content of Premarket Submissions for Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD)
- Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers
- Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care
- Medical Device Shortages - Implementation of Section 506J of the Federal Food, Drug, and Cosmetic Act
- Clinical Considerations for Medical Device Premarket Submissions Targeting Opioid Use Disorder
B-List: Guidance Documents that CDRH Intends to Publish, as Guidance Development Resources Permit in FY2022
Final Guidance Topics
- Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices
- Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations
Draft Guidance Topics
- Questions & Answers Regarding Certificates for Devices Not Exported from the United States (CDNE)
- Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations - Premarket Notification (510(k)) Submissions
- Content of Human Factors Information in Medical Device Marketing Submissions
- Marketing Submission Recommendations for A Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions
- Risk Categorization for Software as a Medical Device: FDA Interpretation, Policy, and Considerations
1982 Final Guidances
1992 Final Guidances
- Review Criteria for Premarket Approval of In Vitro Diagnostic Devices for Detection of Antibodies to Parvovirus B19
2002 Final Guidances
- Sterilized Convenience Kits for Clinical and Surgical Use: Final Guidance for Industry
- General Principles of Software Validation: Guidance for Industry and FDA Staff
- Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery - Guidance for Industry
- Needlesticks - Medical Device Reporting Guidance for User Facilities, Manufacturers, and Importers
- Determination of Intended Use for 510(k) Devices - Guidance for CDRH Staff (Update to K98-1)
2012 Final Guidances
- Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions: Guidance for Industry and Food and Drug Administration Staff
- The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems: Guidance for Industry and Food and Drug Administration Staff
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 on the A-list and B-list, as well as proposed policy or information for the FDA to consider for inclusion in these guidances. CDRH also welcomes suggestions for new or different guidance documents and the reasons why a guidance on the topic is needed.
For the retrospective review list, CDRH is seeking suggestions regarding which final guidances should be revised or withdrawn to help inform the 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 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 2022 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 2022 Proposed Guidance Development."