The Food and Drug Administration is seeking comment on its priority of medical device guidance documents it plans to write and finalize in its 2023 fiscal year.

As in previous years, the agency has split the guidance documents into an A-list and a B-list. List A features four draft documents, up from 10 last year, and three of the texts remain from 2022.

Although some unpublished papers have been reported since last year, the FDA has abandoned plans to develop preliminary risk classification guidance for software as a medical device. Also on the agenda is guidance on transitioning COVID-19 products from Emergency Use Authorizations (EUAs).

INSIGHT

The FDA has released 13 of 23 guidance documents planned for 2022, with the majority, 10, coming from the A-list. 

However,a lighter publication schedule than last year, when the FDA proposed 10 draft guidance documents. drive on your A-list, meaning most of your top priorities in 2023 remain for 2022. 

In the next fiscal year, the regulator plans to release preliminary guidance on voluntary summary reporting of malfunctions, clinical considerations for premarket submission of medical devices targeting opioid use disorder, and select updates to guidance for the program of innovative devices. 

All three proposals were also on the FDA's A-list by 2022. The only recently proposed draft guidance in List A covers an e-submission template for de novo applications.

In addition to publishing the four draft guidance documents, the agency plans to finalize seven texts that have already reached the draft stage.

The list of A-list documents expected to be completed includes texts on cybersecurity management and the agency's guidelines for companies to transition to full US FDA approval in the pandemic era that has enabled rapid application of many tests, vaccines and treatments used to combat COVID-19. .

List B for next year contains six proposed draft guidance documents, only one of which was on last year's list. The previously proposed paper covers marketing submission recommendations for a change control plan for AI-enabled device software features.

The FDA's new proposals cover topics such as chemical analysis for biocompatibility assessment and the evaluation of sex- and gender-specific data in clinical trials of medical devices. The officials also plan to conduct a retrospective review of guidance documents that were finalized in 1993, 2003 and 2013.

The review covers about 30 documents, including FDA guidance on submitting premarket notifications for pulse oximeters. The regulator has convened a panel of experts to look into pulse oximeters amid concerns they may delay care by providing incorrect readings for dark-skinned patients.

The FDA is seeking feedback on the relative priority of documents on its A-List and B-List, as well as suggestions on what guidance material it should review or withdraw as part of its retrospective review.