FDA: Draft Guidance For Laboratory-Developed Test Regs Taking Extra Time
This article was originally published in The Gray Sheet
The head of FDA’s diagnostics office is hopeful that draft guidance governing laboratory-developed tests will be issued by year-end, but cautioned that the process is taking more time than expected.
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Although FDA is still developing its lab-developed test regulatory framework, it has agreed not to collect user fees to support its planned review of the tests.
Laboratory-developed tests are not explicitly mentioned in FDA’s 12-page draft guidance on companion diagnostics issued this summer, but the issue attracted significant attention in written comments in response to the document.