Devices

FDA Denies CAD/CADt Device 510(k) Exemption Petition

FDA has denied a 2025 petition that asked the agency to exempt specific radiology computer-aided detection and/or diagnosis (CAD) devices and computer-aided triage and notification devices (CADt) from 510(k) requirements. The agency denial letter says the petition asked for exemption from the premarket notification requirements for the specified devices when:

the manufacturer previously obtained a 510(k);
for subject CAD devices, the manufacturer must have at least one clearance under the same classification regulation;
for subject CADt devices, the manufacturer must have at least one clearance under any of the three classification regulations;
the manufacturer implements a “robust post-market plan, transparency, and training measures” as described in the petition; and
all existing “special controls, quality systems, establishment registration, and device listing requirements remain in force.”

FDA says it received more than 45 comments on the petition, with a majority opposing the proposed partial exemption, while others supported it. The denial cites a 1/21/1998 Federal Register notice listing factors FDA may consider in determining that a 510(k) is not necessary to assure the safety and effectiveness of a Class 2 device.

The denial concludes that based on the agency’s review of the petition, the pro and con comments received on the petition, and FDA’s assessment of each of the factors for exemption in the Federal Register notice, FDA has determined that the information in the petition does not demonstrate that premarket notification is not necessary to assure the safety and effectiveness of the subject devices that may be covered by the proposed partial exemption.

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