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Medical Devices / Regulatory Affairs

Proposal Would Combine FDA Regs for IVDs, Lab-Developed Tests

April 6, 2017
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A legislative discussion draft being floated in Congress would require the FDA to develop one set of regulations governing both in vitro diagnostics (IVDs) and laboratory-developed tests (LDTs) — to create a more predictable and timely path to market.

Currently, the FDA regulates IVDs but does not actively regulate LDTs. The Diagnostic Accuracy and Innovation Act, which is circulating as a discussion draft, would create a new category of products called in vitro clinical tests (IVCTs) that comprised both IVDs and LDTs and would be regulated separately from devices, drugs, and biologics.

The discussion draft would establish FDA jurisdiction over IVCT development and manufacturing while maintaining Centers for Medicare and Medicaid Services’ (CMS) oversight of laboratory operations. It also would establish a regulatory structure for IVCTs that addresses risk classification, premarket requirements, modifications, quality, post-market monitoring, and innovation.

Cosponsors Reps. Larry Bucshon (R-Ind.) and Diana DeGette (D-Colo.) are inviting comments on the draft by April 7. They plan to formally introduce the measure after reviewing the comments, a spokesman for Bucshon said.

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