REGULATORY UPDATE: FDA Releases Small Entity Compliance Guidance for LDT Final Rule

The Food and Drug Administration released a compliance guide on Tuesday to help small entities comply with applicable medical device regulations, consistent with the agency’s laboratory-developed test (LDT) final rule. Small entity guidances are documents issued by FDA to help ensure that small businesses, which often have limited resources, can effectively understand and comply with FDA regulations.

As described in AABB’s summary, the LDT final rule modifies the definition of in vitro diagnostic products (IVDs) to explicitly include LDTs. Since IVDs are defined as devices, all LDTs will now be subject to the regulatory framework governing devices, which includes adverse event reporting, establishment registration, device listing, labeling requirements, investigational use requirements, quality system requirements and premarket review. 

Those with questions may contact regulatory@aabb.org.