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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.