FDA Laboratory-Developed Tests Proposal Comments Pour In by Thousands

As the public comment period closes Monday on the FDA’s rule to regulate laboratory-developed tests (LDT), the FDA has received more than 2,100 remarks — including hundreds in opposition that are identical — that strongly diverge on whether the proposed rule will ensure test reliability or will burden labs with red tape and reduce the availability of tests for infectious diseases.

The proposed rule would end enforcement discretion of LDTs and explicitly regulate the products as in vitro diagnostics (IVDs), categorized as medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

AdvaMed, a trade group for medical devicemakers, did not submit a public comment but instead issued a statement on the subject in late September.

Read the comments on the rule here.

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