Small Entity Compliance Guide – Guidance Document published by FDA
FDA published a final rule in the Federal Register entitled “Medical Devices; Laboratory Developed Tests” (“LDT Final Rule”), amending FDA regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory .
The FDA has published a Guidance document for small entities – “Small Entity Compliance Guide” to assist small entities to comply with the requirements established in FDA regulations as they apply to IVDs, including LDTs.