FDA’s Move to Regulate LDTs Could Reshape the Industry

For decades, FDA has asserted that it has the authority to regulate laboratory-developed tests (LDTs). But on July 31, 2014, FDA took its biggest steps yet toward actively regulating such tests: FDA notified Congress of its intent to issue two draft guidance documents regarding oversight of LDTs, entitled Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) and FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs)referred to as the framework guidance and the notification guidance, respectively.

Under the draft guidance documents, FDA will take a risk-based approach to regulating LDTs. This means that there will be three groups of LDTs: LDTs subject to full enforcement discretion; LDTs subject to partial enforcement discretion; and LDTs subject to full FDA regulation.

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