[Emergo, UL] U.S. FDA Stage 1 Requirements for Laboratory Developed Tests

In its August 22 webinar, the U.S. Food and Drug Administration (FDA) discussed the Stage 1 requirements imposed on laboratory-developed test (LDT) manufacturers.

U.S. FDA Final Rule on LDTs

LDTs are in vitro diagnostic devices (IVDs) that are designed, manufactured and used within a single clinical laboratory and were placed under enforcement discretion in 1976 with the medical device amendments to the Federal Food, Drug, and Cosmetic Act. Since at least 2010, the FDA has been considering regulating most LDTs more like commercially distributed IVDs. In  January, the FDA shared the intended proposal to reclassify most IVDs currently classified as Class III to Class II devices, likely in preparation for regulatory developments related to LDTs.

The Final Rule for LTDs was officially released on May 6, 2024. A four-year phaseout policy from enforcement discretion to standard IVD requirements was announced for most LDTs. Stage 1 applies starting on May 6, 2025.

Final Rule on LDTs, Stage 1

The first set of requirements applicable to LDT manufacturers is complaint management and adverse event, correction and removal reporting requirements. Manufacturers of LDTs must have a procedure to manage complaints, as well as a complaint file system (records), to collect and review complaints per 21 CFR 820.198. Manufacturers must also have the processes to assess if these complaints are reportable as Medical Device Reports (MDR, 21 CFR part 803) and to assess if the LDT is subject to corrections and removals reporting (21 CFR part 806). They must begin making such reports, where applicable, starting on May 6, 2025.

In its quest to keep the industry educated, the FDA hosted a webinar on Stage 1.

 

 

US FDA Stage 1 Requirements for Laboratory Developed Tests and Webinar | Emergo by UL

U.S. FDA Stage 1 Requirements for Laboratory Developed Tests

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