December 6, 2022
The US Food and Drug Administration has released a list of guidance documents it plans to issue over its 2023 fiscal year. FDA’s Center for Radiological Health (CDRH) publishes the list of planned topics each year, divided into higher priority “A-list” final and draft guidance topics, as well as a “B-list” of guidance documents to be published as agency resources allow. Finally, CDRH publishes a “Retrospective review” list of guidance documents issued in previous years that may benefit from revision.
The planned guidance topics from the FDA’s CDRH provide a level of transparency so that US medical device market applicants and registrants may know what areas to focus on to achieve compliance.
What are the CDRH A-list of regulatory priorities for 2023?
The FDA’s CDRH has prioritized guidance documents on its A-list on subjects such as transitioning COVID-19 devices from emergency use authorizations (EUAs) to traditional marketing pathways once the public health emergency (PHE) ends. The agency is also focusing on current digital health issues, including cybersecurity.
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 (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
Draft guidance topics: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
CDRH B-list of regulatory guidances for 2023
Although the agency isn’t sure which of its B-list topics will get published over the course of its fiscal year, US market registrants will want to watch some of the topics that may impact their medical device business.
B-list final guidance topics:
- Peroxide-based contact lens care products – Patient labeling recommendations
B-list draft guidance topics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
Final past guidances and feedback
The FDA has also added a list of final guidances from the past that may warrant revision as staffing and budgets allow, including a number of product-specific 510(k) guidances as well as guidances on clinical trials. The agency includes these past guidances to ensure that final guidance documents continue to provide industry with the agency’s current viewpoints and considerations.
FDA works with stakeholders to conduct a review of previously issued final guidance documents. Since FY 2015, CDRH has provided a list of final guidance documents that are up for annual review on the FDA.gov website. You may comment on the relevancy of planned guidance documents via FDA.gov.
Emergo by UL will continue to post updates to FDA guidance as they become available.