From DAIA to the VALID ACT: The Latest Chapter in FDA Diagnostic Test Oversight Reform

While FDA oversight over new diagnostic tests is perfectly acceptable, what is objectionable is the agency’s continued reliance on a regulatory regime designed not for lab tests but medical devices. Accordingly, the industry had high hopes for proposed legislation that would remove diagnostic tests from the FDA’s Section 510(k) process. But now the future of that bill has come into doubt. The good news, however, is that the apparent successor bill may provide the relief necessary to facilitate the approval of new diagnostic tests.

The DAIA Bill. . .

For the past two years, a bi-partisan bill called the Diagnostic Accuracy and Innovation Act (DAIA) has been working its way through Congress. DAIA, which enjoys bi-partisan support in both houses, would remove diagnostic tests from the definition of a medical device and thus outside the scope of the FDA’s 510(k) process for medical devices which requires test makers to compare their assays to products approved back in the 1980s.

After hearing from both industry and the FDA, legislators drew up a draft of the DAIA bill and submitted it to the agency for technical assistance. But instead of the expect technical edits, the FDA proposed an entirely new framework to overhaul and modernize the 510(k) premarket review program to bolster medical device and diagnostic safety and advance new technologies.  Under the proposed plan:

• Manufacturers would use more modern predicate devices of object performance criteria when they seek 510(k) clearance;
• The FDA would publicize devices and manufacturers that rely on predicates that that are over 10 years old;
• The FDA would finalize guidance establishing an alternative 510(k) pre-certification pathway allowing manufacturers of certain-well-understood device types to rely on objective safety and performance criteria to demonstrate substantial equivalence as a way to make it more efficient to adopt modern criteria as the basis for predicates that are used to support new products.

Additionally, FDA proposed to finalize its Expanded Abbreviated 510(k) draft guidance, which was issued in April 2018, in early 2019 and rename it the “Safety and Performance Based Pathway.” Industry reaction to the FDA proposal was lukewarm at best. See, National Intelligence Report, September 2018.

. . . Morphs into the VALID Act

Now that Congress is back in session, the Representatives and Senators who originally sponsored DAIA have incorporated the FDA’s ideas, including the pre-certification program concept, into a discussion draft of a new bill called the Verifying Accurate, Leading-edge IVCT Development (VALID) Act. Unlike DAIA, the VALID Act also makes FDA’s authority to regulate IVCTs, and therefore LDTs, explicit. The aim is to establish a framework for overseeing IVCT’s at the FDA.

The lab industry sees both good and bad in the new approach. While there’s concern that the FDA proposal doesn’t have a clear timeline, the industry is intrigued with the idea of a pre-certification process. Meanwhile, the sponsors of the VALID Act are hoping to make it a legislative priority, touting it as a sensible, risk-based approach towards regulation of IVCTs that protects innovation in an ever-changing sector of healthcare.