Devices

FDA Promoting Development of Opioid Crisis Devices

FDA has started an “innovation challenge” to encourage development of medical devices, including digital health technologies and diagnostic tests, that could provide novel solutions to detecting, treating, and preventing addiction, addressing diversion, and treating pain. Companies selected by the agency to participate in the challenge will have an opportunity for closer interaction with FDA to accelerate development and review of their products, according to an agency news release.

Developers are encouraged to submit proposals for review by a CDRH team that will look at product feasibility, potential public health impact, and novelty of the concept. Proposals will be accepted from 6/1 through 9/30, and selected applicants are to be announced in November.

Proposals could include products such as diagnostics to identify patients at increased risk for addiction, treatments for pain that eliminate the need for opioid analgesics, treatments for opioid use disorder or symptoms of opioid withdrawal, and devices or technologies that can prevent diversion of prescription drugs.

“The challenge is open to products in any stage of development, from concept to testing,” the notice says. “The challenge also is open to developers of currently marketed products who are interested in demonstrating that their device has an improved benefit-risk profile as compared to opioids in the management of pain.”

Developers accepted into the challenge will receive enhanced interactions with FDA review divisions during the development and evaluation of the proposed product and breakthrough device designation will be granted to those devices that meet the statutory criteria for designation without submission of a separate application. FDA says it expects that in most cases, applicants will eventually submit one or more formal applications — IDE, 510(k) or PMA.

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