Lab-Developed Tests Get a Break in User Fee Legislation

Laboratory-developed tests (LDTs) got a break in medical device user fee legislation that passed the Senate June 26 and now goes to the President. The bill allows the FDA to waive user fees on LDTs over the next five years and strictly limits the number of LDTs that the agency can target for premarket approval and subject to user fees. The bill also requires the FDA to notify Congress 60 days in advance of issuing any guidance on LDT regulation and report on what it is planning to do to implement the guidance.