By Allyson B. Mullen & Jeffrey N. Gibbs
On July 31, 2014, in accordance with Section 1143 of the Food and Drug Administration Safety and Innovation Act (FDASIA), FDA notified Congress of its intent to issue two draft guidance documents regarding oversight of laboratory developed tests (LDTs). FDA, Notification to Congress, July 31, 2014. The two draft guidance documents are entitled “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” (the Framework Guidance) and “FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs)” (the Notification Guidance) – the guidances are available via the same link as the notice to Congress. On the same day, FDA rejected the Washington Legal Foundation’s citizen petition challenging FDA’s authority to regulate LDTs. Brushing aside WLF’s arguments, FDA unequivocally stated it could regulate LDTs as devices and do so through guidance documents, not rulemaking.
At long last, we now know how FDA intends to regulate LDTs – and it’s not pretty. Of course we will have a much more detailed analysis of the draft guidance documents once we have had time to fully digest these documents, but for now we wanted to share a high-level summary.
continue to read here
On July 31, 2014, in accordance with Section 1143 of the Food and Drug Administration Safety and Innovation Act (FDASIA), FDA notified Congress of its intent to issue two draft guidance documents regarding oversight of laboratory developed tests (LDTs). FDA, Notification to Congress, July 31, 2014. The two draft guidance documents are entitled “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” (the Framework Guidance) and “FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs)” (the Notification Guidance) – the guidances are available via the same link as the notice to Congress. On the same day, FDA rejected the Washington Legal Foundation’s citizen petition challenging FDA’s authority to regulate LDTs. Brushing aside WLF’s arguments, FDA unequivocally stated it could regulate LDTs as devices and do so through guidance documents, not rulemaking.
At long last, we now know how FDA intends to regulate LDTs – and it’s not pretty. Of course we will have a much more detailed analysis of the draft guidance documents once we have had time to fully digest these documents, but for now we wanted to share a high-level summary.
continue to read here
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