The quinquennial user fee process for medical devices has always proven controversial, but the FDA and industry have missed a Jan. 15 deadline for an agreement to be presented to Congress. Recently, several members of the House and Senate inked a letter to the FDA about the missed deadline, a signal that the agency’s aspirations for a $2.5 billion user fee deal are in jeopardy.

The U.S. Centers for Medicare & Medicaid Services’ (CMS) withdrawal of a proposal to provide automatic coverage of FDA-designated breakthrough devices has drawn criticism from device makers, but the industrial reaction runs the gamut.

The FDA’s July 27 webinar on medical device servicing and remanufacturing lent some clarity to the terms of a recent draft guidance on the subject, but there are several overarching policy concerns. The FDA’s Joshua Silverstein said on the webinar that the agency sees servicing as a type of manufacturing, a view that is contradicted by the Medical Imaging & Technology Alliance, which indicated earlier this year that third-party servicers are probably not subject to the regulations applied to manufacturers.

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program, or STeP, is designed in part as a complement to the breakthrough devices program, but the September 2019 draft guidance lent little clarity as to what might constitute a significantly safer device.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.