Devices

Gottlieb Touts LDT Advances

FDA commissioner Scott Gottlieb told the American Clinical Laboratory Association annual meeting 3/6 that the agency is “working hard to make sure that as inventive new tests come to us for review, we have the right tools to evaluate cutting-edge technologies. And we have the right processes in place so we can do our job of reviewing for clinical and analytical validity when we’re asked to, so important new diagnostic tools are more quickly adopted into clinical practice.”

His presentation focused on the agency’s new approaches to its review of diagnostics, including the pre-certification pilot program, qualification of the New York State Department of Health as a third-party reviewer, and the agency’s “flexible, modern” approach to review of next generation sequencing (NGS).

For next-generation sequencing, he said, FDA is developing several policies designed specifically to improve the development and review of advanced NGS technologies. “We recently provided public information describing the three-tiered approach that FDA is taking to our review of NGS oncopanel tests in order to minimize the burden on developers,” he said. “Under this approach, we’re communicating with developers about the flexibility they have in developing analytical and clinical evidence to support marketing authorization, depending on the type of claim being made…. By communicating clearly, we hope to enable less burdensome review and better-informed development programs.”

The commissioner also said the agency is developing policies that will permit more tests to be exempt from the burdens of premarket review. For some tests, he said, FDA may be able to establish initial controls that provide a reasonable assurance of analytical and clinical validity. He said the agency is also looking into new, innovative approaches to demonstrating analytical and clinical validity.

Gottlieb traced the advances in laboratory-developed tests from the relatively simple tests of the 1970s to today’s sophisticated, innovative, and important tests. “In view of these developments,” he said, “we must continue to ask ourselves how we adapt payment schemes, regulations, [and] enforcement policies that were designed for the technologies and market of the 1970s for today’s innovations.”

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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