Devices

5 Guidances Updating 510(k) Program

FDA says it has issued four draft guidances and updated a final guidance relating to the Safety and Performance Based Pathway as part of its commitment to strengthening and modernizing the 510(k) program.

The updated Safety and Performance Based Pathway guidance gives the agency’s current thinking on the concept of the abbreviated 510(k) program for demonstrating substantial equivalence for 510(k) submissions. The document describes an optional pathway — the Safety and Performance Based Pathway — for certain, well understood device types, under which a submitter would demonstrate that a new device meets FDA-identified performance criteria to demonstrate that the device is as safe and effective as a legally marketed device. It focuses on the decision point of the substantial equivalence analysis that requires a 510(k) submitter to demonstrate that, despite technological differences, its device is as safe and effective as a legally marketed device.

The four draft guidances released in the package discuss the performance criteria for the Safety and Performance Based Pathway for four medical devices: conventional Foley catheters, cutaneous electrodes for recording purposes, orthopedic non-spinal metallic bone screws and washers, and spinal plating systems.

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