Major FDA Changes – The Final Rule on LDTs (Lab Developed Tests):  Many companies who sell home test kits for STDs, drug abuse tests and similar OTC, e.g., on Amazon, CVS, Walgreens, etc., have relied heavily on the FDA’s tacit neglect under FDA’s “selective enforcement” of LDTs and their definition and legal requirements.  This now has changed radically with the issuance of the FDA’s Final Rule in the Federal Register (US law) on LDTs, on July 5, 2023¹.

 In their Final Rule, the FDA has brought LDT’s back to their original intent, i.e., a limited category of tests, manufactured / assembled by CLIA (Clinical Laboratory Improvement Amendments of 1988) labs, for which no viable alternative in IVT’s / other medical devices exist and for which “targeted selective enforcement” would be employed. All other “LDT” devices will be treated by the FDA as medical devices / IVDs. There will be a 5-stage 4-year phase-out² to full compliance. The phase-out dates start with the publication date of May 6, 2024. This Final Rule will pose major problems for current suppliers of so-called LDTs to clinicians, Amazon, CVS, Walgrens, etc.

 All LTV’s are medical devices, and now will be regulated as such, per the Final Rule, including company (commercial manufacturer / lab) registration, device listings, premarket review (510(k), PMA, IDE, De Novo) where applicable (Class II and III), adherence to the CGMPs for devices (21 CFR 820 / ISO 13485), FDA inspections, US FDA MDR reporting  (Medical Device Reporting), Labeling requirements, et al.  

 ¹Final Rule, LDTs:  https://www.federalregister.gov/documents/2024/05/06/2024-08935/medical-devices-laboratory-developed-tests

 ²Phase-out Schedule:  https://www.fda.gov/medical-devices/laboratory-developed-tests-faqs/phaseout-policy-and-enforcement-discretion-policies-laboratory-developed-tests-faqs

-- jel@jelincoln.com