Negotiations between the FDA and industry over the next device user fee are going on behind closed doors, but the agency’s summaries of these meetings suggest there are sharp disagreements. While the FDA continues to press industry on additional fees for the total product life cycle advisory program, industry’s dissatisfaction with the FDA’s fiscal management of the user fee program has prompted a demand for a one-off audit of the agency’s use of those user fees.
The U.S. FDA’s safer technologies program, or STeP, may seem uncontroversial, but agency staff said on a Feb. 1 conference call that the program could be delayed by the change in administration at the White House. This is possibly an artifact of the Biden administration’s Jan. 20 executive order (EO) that applies a freeze to federal agency activities for 60 days, an EO that could affect a wide swath of federal agency activity.
The U.S. FDA’s safer technologies program, or STeP, is designed in part as a complement to the breakthrough devices program, but the September 2019 draft guidance lent little clarity as to what might constitute a significantly safer device. The Jan. 5, 2021, final guidance does little to clarify that question, however.
The FDA’s Safer Technologies Program, or STeP, is part of an overarching emphasis on safety, and the related draft guidance focuses largely on the process of applying for a STeP device. However, a member of the FDA staff said on a webinar that device accessories – and devices that make other devices safer – are also eligible for the program.