Devices

Changes in Sequencing Guidances Explained

A 5/24 CDRH Webinar on two precision medicine guidances outlined major changes between the 2016 draft guidances and the final documents issued 4/13. During the Webinar, Adam Berger from the CDRH precision medicine staff, said the scope of the final guidance on design, development, and analytical validation of next generation sequencing (NGS)-based in vitro diagnostics was clarified in response to comments on the draft that say the guidance only specifically applies to NGS-based tests that FDA continues to believe could form the basis of future FDA-recognized standards and/or special controls that could reasonably assure the tests’ safety and effectiveness.

The final guidance lays out a potential pathway whereby NGS-based tests intended to aid in the diagnosis of suspected germline diseases could be considered as candidates for down-classification to Class 2 devices, since all novel tests are Class 3 by default.

Berger said commenters were generally supportive of the proposed regulatory approach and asked for clarification of the background, scope, and certain technical recommendations. The guidance title was revised to better reflect scope and content, to acknowledge that currently there are no applicable standards that FDA can recognize, and to support community engagement in developing standards by standards-developing organizations.

He also explained that the analytical performance thresholds were removed from the final guidance, which now recommends that test developers pre-define, justify, and report minimum acceptable overall and target threshold metrics such as accuracy, precision, and coverage. Finally, clarifications in accuracy metrics, performance evaluation studies, and other technical recommendations were made in the guidance.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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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