CLN - Regulatory Roundup

FDA Creates Streamlined Regulatory Pathway for NGS-Based Cancer Profiling Tests

Regulatory Roundup: January-February 2018

The Food and Drug Administration (FDA) has unveiled a more efficient process for authorizing next-generation sequencing (NGS)-based cancer profiling tools that aims to reduce the burden on test developers and spur innovation. As a first step in establishing this new regulatory pathway, the agency has accredited the New York State Department of Health (NYSDOH) as an FDA third-party reviewer of in vitro diagnostics. Moving forward, if manufacturers have received NYSDOH approval for an NGS-based tumor profiling test, they will no longer need to submit a separate 510(k) application to FDA. Instead, developers may choose to request that New York state forward their NYSDOH application, as well as the state’s review memorandum and recommendation, to FDA for consideration. In the future, other accredited, third-party FDA reviewers also may become eligible to conduct such reviews and make clearance recommendations to the agency.

In addition, FDA is establishing a class II regulatory pathway for the review of NGS-based tumor profiling tests. Class II designation makes these tests eligible to go through FDA’s 510(k) clearance process, either via an application submitted directly to the agency or through an accredited third-party reviewer.