Compelo Medical Devices is using cookies

We use them to give you the best experience. If you continue using our website, we'll assume that you are happy to receive all cookies on this website.

ContinueLearn More
Close
Dismiss

Petition For LDT Regulation Subject Of Industry Debate

Whether the US Food and Drug Administration (FDA) should be regulating all laboratory-developed tests (LDTs) is stirring up a debate among devicemakers, industry groups and professional associations. Several stakeholders have submitted comments to a docket addressing a citizen petition filed by Genentech, Inc. in December 2008.

Petition requested FDA to require all in vitro diagnostic tests intended for use in drug or biologic therapeutic decision-making to be held to the same scientific and regulatory standards, regardless of whether they are developed and sold by device manufacturers as test kits or by laboratory-based companies for in-house testing.

Genentech is a biotechnology company that discovers, develops, manufactures and commercializes pharmaceutical products to treat patients with unmet medical needs.