ARTICLE SUMMARY:
The team at CDRH who was in charge of reviewing Small Business Determination requests was put on administrative leave in April, leading device companies to face delays and ambiguity in qualifying for reduced user fees for premarket submissions.
Small device companies seeking to qualify for reduced user fees have been facing a backlog at FDA after the team that handled such requests was laid off in April. The slowdown is forcing more firms to decide whether to hold off on a planned submission, such as a 510(k), in the hope of getting the 75% fee discount or moving forward and paying full price.
The logjam is a direct result of HHS’ April 1 “reduction in force” action that led to more than 200 staffers at FDA’s device center (CDRH) being put on administrative leave (the final separation date for impacted employees was supposed to be June 2, but courts have paused the layoffs). One department eliminated by the cuts was CDRH’s Office of Management, which, among its portfolio of responsibilities, reviewed Small Business Determination (SBD) requests to affirm whether a company’s most recent tax year revenue was no more than $100 million and, thus, qualifies for reduced fees.
