FDA fi­nal­izes long-await­ed rule to bring lab tests un­der its purview

The FDA on Mon­day fi­nal­ized a long-await­ed rule that out­lines how it will reg­u­late lab­o­ra­to­ry-de­vel­oped tests (LDTs) as med­ical de­vices, even though some crit­ics say the FDA is over­step­ping its au­thor­i­ty.

The agency said the rule is need­ed to more close­ly reg­u­late LDTs for safe­ty and ac­cu­ra­cy, but groups rep­re­sent­ing labs have ar­gued that hav­ing the FDA reg­u­late tests could slow in­no­va­tion and make it hard­er for pa­tients to get care.

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