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

April 14, 2017

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.

The device regulatory landscape is changing. The newly passed 21st Century Cares Act doesn’t just force an adjustment of the FDA’s policies. It calls for a sea of change in the waters you have learned to navigate so well. Devicemaker’s Guide to the 21st Century Cures Act tells you what to expect in the coming months, which new provisions are likely to cause trouble and how to get out in front of the changes.

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