Nathan Brown Quoted on Anticipated FDA LDT Rule

For its article, “Lab Industry Looks to Recently Added Regulatory Tool for Flexibility as FDA LDT Rule Looms,” 360Dx quoted health care & life sciences partner Nathan Brown. The article discusses how the lab industry is looking to the U.S. Food and Drug Administration's (FDA) emerging policy on Predetermined Change Control Plans (PCCPs) for flexibility in anticipation of the forthcoming regulation on laboratory-developed tests (LDT).

According to Brown, while the concept of PCCPs “is not entirely new,” the inclusion of the provision in the Food and Drug Omnibus Reform Act of 2022 has “codified and clarified” its use as a tool for the FDA and submitters. Nathan, who played a role in developing the legislation, noted that the FDA has previously incorporated PCCPs on a case-by-case basis.

The article notes uncertainties regarding the use of PCCPs, such as whether they could be employed to add new viruses to a respiratory panel or new drugs of abuse to a toxicology panel. Nathan suggested that there is room for interpretation, saying “There's definitely some play in the joints in terms of how for a particular device FDA would define the intended use versus the indications for use.”

However, Nathan expects that the FDA will recognize the value of PCCPs in managing the expected increase in test submissions if the agency's rule on LDT regulation is implemented. He believes that PCCPs should be given significant consideration and become a central aspect of the regulatory framework. “[I]t should be front and center,” he said.

Nathan also acknowledges that initially, applications with PCCPs may undergo longer review times as the FDA establishes its evaluation process. However, he predicts that as more applications with PCCPs are submitted and approved, the handling of PCCPs will become more routine and standardized.