FDA rolls out long-awaited proposal to overhaul diagnostics regulation

The FDA on Fri­day un­veiled a long-await­ed pro­posed rule that aims to over­haul how the agency reg­u­lates di­ag­nos­tic tests, bring­ing thou­sands of new tests un­der its purview.

The 83-page pro­posed rule makes ex­plic­it that in vit­ro di­ag­nos­tics would be reg­u­lat­ed as med­ical de­vices in the eyes of the FDA, and it would phase out its en­force­ment dis­cre­tion ap­proach for lab­o­ra­to­ry-de­vel­oped tests (LDTs) over a pe­ri­od of four years. The rule ful­fills FDA of­fi­cials’ com­mit­ments in re­cent months to pur­sue rule­mak­ing to over­haul the agency’s frame­work for reg­u­lat­ing di­ag­nos­tic tests in the ab­sence of con­gres­sion­al ac­tion.

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