FDA Issues Draft Guidance on Laboratory Developed Tests

October 3, 2014 | Today, the FDA officially issued a pair of draft guidance documents outlining its regulatory plans for laboratory developed tests (LDTs). The documents are substantially identical to the oversight framework for LDTs that the FDA released to the public on July 31. Bio-IT World previously published an explainer on this oversight framework, while our sister site, Clinical Informatics News, published a feature exploring the implications of new LDT regulations for the American healthcare system and the future of molecular diagnostics.

The draft guidance documents, "Framework for Regulatory Oversight of Laboratory Developed Tests" and "FDA Notification and Medical Device Reporting for Laboratory Developed Tests," are available online. There will now be a 120-day public comment period; anyone wishing to submit a formal comment on either document can do so through the Federal Register. The FDA has stressed that it will take comments into consideration before finalizing its guidance on LDTs.

"We see this as starting the discussion with the community, not necessarily where we’ll end up," says Katie Serrano of the FDA's Office of In Vitro Diagnostics.