CDRH Proposed Guidances for Fiscal Year 2023 (FY2023)
The lists on this page include guidance documents the FDA’s Center for Devices and Radiological Health (CDRH) intends to publish this fiscal year (FY2023), 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for which CDRH is interested in receiving external feedback regarding whether these guidances should be revised or withdrawn.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 FY2023.
- The B-list: A list of device guidance documents the FDA intends to publish as resources permit during FY2023.
- Retrospective review list: A list of final guidance documents issued in 1983, 1993, 2003, and 2013.
On this page:
- Retrospective review list for 1983, 1993, 2003, and 2013
- How to comment on these guidance lists or a specific guidance
A-List: Prioritized Guidance Documents that CDRH Intends to Publish in FY2023
Final Guidance Topics
- Remanufacturing of Medical Devices
- 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 Device Software Functions
- Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program
- Breakthrough Devices Program (revised)
Draft Guidance Topics
- Voluntary Malfunction Summary Reporting (VMSR) Medical Device Reporting (MDR) for Manufacturers
- Clinical Considerations for Medical Device Premarket Submissions Targeting Opioid Use Disorder
- Select Updates for Guidance for the Breakthrough Devices Program
- Electronic Submission Template for De Novo Request Submissions
B-List: Guidance Documents that CDRH Intends to Publish, as Guidance Development Resources Permit in FY2023
Final Guidance Topics
- Peroxide-Based Contact Lens Care Products – Patient Labeling Recommendations
Draft Guidance Topics
- Chemical Analysis for Biocompatibility Assessment of Medical Devices
- Marketing Submission Recommendations for A Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions
- Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies (revision of Evaluation of Sex-Specific Data in Medical Device Clinical Studies)
- The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program
- Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program
- Biocompatibility Testing of Medical Devices – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program
Retrospective Review List of Guidances for 1983, 1993, 2003, and 2013
1983 Final Guidances
1993 Final Guidances
- Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology
- Guidance for the Content of Premarket Notifications for Ureteral Stents
- Guidance on Premarket Notification 510(k) for Sterilizers Intended for Use in Health Care Facilities [also see Addendum to: Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities 9/95]
- Guidance on the Content of Premarket Notification [510(K)] Submissions for Clinical Electronic Thermometers
- Guidance on the Content of Premarket Notification [510(K)] Submissions for Hypodermic Single Lumen Needles
- Guidance on the Content of Premarket Notification [510(K)] Submissions for Piston Syringes
- Letter to Industry, Powered Wheelchair Manufacturers from RMJohnson
- Beam Attenuators and Emission Indicators for Class II and IIIa Laser Systems (Laser Notice 43)
- Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes
- Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities
- Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators
- Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Sharps Containers
2003 Final Guidances
- Quality System Information for Certain Premarket Application Reviews
- User Labeling for Devices that Contain Natural Rubber (21 CFR 801.437); Small Entity Compliance Guide
- Pediatric Expertise for Advisory Panels - Guidance for Industry and FDA Staff
- Coronary and Peripheral Arterial Diagnostic Catheters - Guidance for Industry and FDA Staff
- Frequently-Asked-Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors - Three Additional Questions
- Information Disclosure by Manufacturers to Assemblers for Diagnostic X-ray Systems - Guidance for Industry and FDA Staff
- Premarket Approval Application Modular Review: Guidance for Industry and FDA Staff
- Premarket Notification [510(k)] Submissions for Chemical Indicators - Guidance for Industry and FDA Staff
2013 Final Guidances
- CPG Sec. 390.225 Early Defects or Noncompliance - 21 CFR 1004.6
- Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation - Guidance for Industry and Food and Drug Administration Staff
- Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff
- Investigational Device Exemption (IDE) Guidance for Retinal Prostheses
- Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi - Guidance for Industry and FDA Staff
- Medical Device Classification Product Codes - Guidance for Industry and Food and Drug Administration Staff
- Assay Migration Studies for In Vitro Diagnostic Devices
- Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and FDA Staff
- Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies: Guidance for Industry and Food and Drug Administration Staff
- Design Considerations for Pivotal Clinical Investigations for Medical Devices: Guidance for Industry, Clinical Investigators, Institutional Review Boards and FDA Staff
- Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Guidance for Industry and FDA Staff
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 by December 16, 2022.
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 "Instructions for Submitting Comments on the CDRH Fiscal Year 2023 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 document entitled "Instructions for Submitting Comments on the CDRH Fiscal Year 2023 Proposed Guidance Development" located on www.regulations.gov under docket number FDA-2012-N-1021.
Metrics for FY 2022 A-list and B-list Publication
Stakeholder feedback on guidance priorities is important to ensure that the CDRH guidance program meets the needs of stakeholders. The feedback received on the FY 2022 list was mostly in agreement, and CDRH continued to work toward issuing the guidances on this list. In FY 2022, CDRH published 13 of 23 guidances on the FY 2022 list (10 from the A-list, 3 from the B-list). Although CDRH has decided not to pursue the development of the draft guidance “Risk Categorization for Software as a Medical Device: FDA Interpretation, Policy, and Considerations” at this time, we are pursuing further refinement of the framework through the International Medical Device Regulators Forum (IMDRF).1
Metrics for the Finalization of Draft Guidance Documents
The percentage of draft guidances issued FY 2016 onward that CDRH has finalized, withdrawn, reopened the comment period, or issued new draft guidance within 3 years or within 5 years of the comment period close is as follows:
|FY||Action taken within 3 years||Action taken within 5 years|
|FY 2016||23 of 29 (79%)||25 of 29 (86%)|
|FY 2017||6 of 6 (100%)||6 of 6 (100%)|
|FY 2018||22 of 24 (92%)||5 years not yet reached|
|FY 2019||21 of 25 (84%)||5 years not yet reached|
In addition, in FY 2022, 9 draft guidances issued prior to October 1, 2016, remain for which no action has been taken yet, and CDRH has been continuing to work towards taking an action on these remaining draft guidances. Looking forward, in FY 2023, CDRH will strive to finalize, withdraw, or reopen the comment period for 50 percent of existing draft guidances issued prior to October 1, 2017.
Applicability of Previously Issued Final Guidance
In FY 2022, CDRH received comments regarding guidances issued in 2012, 2002, 1992, and 1982 and the revision of several guidance documents is being considered as resources permit.
- 1. https://www.imdrf.org/working-groups/software-medical-device