Transition Plans for Covid-19 Products are Amongst CDRH FY2023 Priorities

Last week, our blog post advised planning a transition strategy in advance of the news of the termination of the Covid-19 public health emergency. On October 17, 2022, FDA published the list of CDRH proposed guidances for FY 2023 (see here). Amongst CDRH’s highest prioritized device guidance documents are final versions of the transition plans for medical devices that fall within enforcement policies or that were issued emergency use authorizations (EUAs) during Covid-19 public health emergency (PHE). These are documents on the A-list, a list of prioritized documents that FDA intends to publish during FY2023. FDA published draft guidances for these topics in December 2021 (here and here). This prioritization suggests that the transition guidances will very likely be published this fiscal year. Some other final guidance documents on this A-list include 1) cybersecurity in medical devices: quality system considerations and content of premarket submissions and 2) breakthrough devices program (revised).

On the FDA’s B-list, a list of documents that FDA intends to publish as resources permit during FY2023, are final guidance on peroxide-based contact lens care products and draft guidances on 1) chemical analysis for biocompatibility assessment of medical devices and 2) marketing submission recommendations for a change control plan for artificial intelligence/machine learning (AI/ML)-enabled device software functions. This AI/ML guidance is much needed, particularly as the use of AI/ML in medical devices continues to expand (see FDA’s recent list of AI/ML-enabled devices published earlier this month, here).

Also part of FDA’s FY2023 guidance document plan is a retrospective review of guidance documents issued in 1993, 2003, and 2013. The 1993 guidance documents largely pertain to 510(k) submissions for various device types (e.g., electronic thermometers, single lumen needles, piston syringes). FDA’s retrospective review of the 2003 guidance documents will include user labeling for devices that contain natural rubber and premarket approval application modular review. The 2013 guidance documents include, but are not limited to, in vitro diagnostic and clinical trial considerations.

CDRH is open to feedback on the relative priority of those documents identified on the A-list and B-list. They are also open to information to include in these guidance documents. If you would like to provide suggestions in the transition plan for Covid-19 related products or any other guidance documents, comments may be submitted to www.regulations.gov by December 26, 2022.

As we emphasized in our previous blog post, the termination of COVID-19 PHE could complicate the business plan for some medical product companies. If you are currently marketing your products via EUA or COVID‑related enforcement discretion, we suggest you start to develop a transition strategy to be able to continue to market such products after the EUA termination date. If you are currently considering drafting an EUA application for your product, remember that the time you could enjoy the EUA authorization may not last long. Such companies should at least consider a “hybrid” approach to bring the products to the market via an EUA for the time being, but at the same time, prepare for a traditional regulatory submission (e.g., 510(k) premarket notification, de novo request, or PMA).