FDA recently notified Congress that it intends to end its long-standing policy of enforcement discretion in the area of Laboratory Developed Tests ("LDTs"). Letters from the Agency to Senate and House oversight committees included two attachments containing anticipated details of draft guidance documents on how the Agency intends to regulate LDTs. The first document, titled Framework for Oversight of Laboratory Developed Tests, is a self-described "risk-based framework for addressing the regulatory oversight" of LDTs aimed at clinical laboratories that manufacture LDTs. The second document, FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs), proposes specific instructions for laboratories to notify the FDA about its existing and future LDT products. Both documents describe FDA's priorities for pre- and post-market requirements for LDTs and how FDA will phase in different kinds of LDTs over time.
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