Devices

Detailed Review of 3 FDA Software Precert Documents

King & Spalding attorneys have posted a detailed review of three documents released by FDA 1/7 relating to the agency’s software precertification pilot program. The documents are: (1) the Developing a Software Precertification Program: A Working Model (Version 1.0); (2) the Software Precertification Program: 2019 Test Plan; and (3) the Software Precertification Program: Regulatory Framework for Conducting the Pilot Program within Current Authorities.

The attorneys say the documents “are critical to the digital health community, including artificial intelligence companies, because they offer an opportunity to engage in the development of what hopefully will be a much more efficient, effective, and flexible system for approving cutting-edge software and digital health devices. The documents also mark the beginning of the long-anticipated ‘test phase’ of the Pre-Cert Pilot Program and, eventually, the launch of the final Pre-Cert Program.”

The review concludes that the new program has the potential to offer manufacturers of medical device software a faster route to FDA approval, provided they have a history of “excellent” product quality and safety, conduct clinical research responsibly and practice good cybersecurity hygiene, and engage in proactive self-assessment and self-surveillance.

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