Devices

FDA Proposes New Diagnostic Test Regulatory Scheme

Responding to a request for FDA technical assistance on the Diagnostic Accuracy and Innovation Act, the agency has advanced a different framework with different statutory language that would substantially change the regulatory regime for in vitro diagnostics (IVDs), according to a blog post by attorney Jeffrey Gibbs (Hyman, Phelps & McNamara). In his firm’s FDA Law Blog, Gibbs says FDA reported it is “taking a fresh look at how the agency is encouraging the development of innovative tests and continuous improvement to diagnostics already on the market.” Underscoring that its technical assistance is not just tweaking existing mechanisms, Gibbs adds, FDA says it “believes it is necessary to create pathways.”

If the FDA proposals were adopted, Gibbs writes, labs and manufacturers would be subject to the same criteria for when applications would need to be submitted. Labs would also be subject to other FDA requirements beyond the submission of marketing applications.

The most striking change, according to Gibbs, is not putting kits and laboratory-developed tests on the same footing, but rather the rewriting of the IVD regulatory process, both for entering and for remaining on the market. “Many of the regulatory terms and constructs that have governed IVD regulation for decades would be discarded,” he reports. “A whole new vocabulary would be adopted, complete with their own statutory definitions…. This legislation, although it borrows from some past concepts, should be viewed as revolutionary, not evolutionary.”

Gibbs says the FDA technical assistance document will be controversial, with numerous questions raised about the specifics. “The momentum for overhauling the way IVDs are regulated is growing,” he concludes. “Multiple stakeholders have endorsed the concept. FDA’s technical assistance is consistent with the principle that change is necessary, albeit there are numerous differences in approach and details. FDA was asked for its views, and it was not going to throw away its shot by limiting itself to minor technical comments.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome