Devices

Special 510(k) Pilot Program Begins 10/1

FDA 10/1 launched a revised Special 510(k) Pilot Program that aims to expand on the types of changes eligible for the program to improve the efficiency of 510(k) review. As part of this pilot, certain design or labeling changes that previously were reviewed as a traditional 510(k) may be eligible to be reviewed through the Special 510(k) pathway instead, an agency notice says.(XXINSERTT LINKXXX) FDA believes that the reliance on design control requirements and previous agency review of detailed information can reduce review times and still protect the public health, it says. The notice outlines the factors that should be me to participate in the pilot.

Last week, the agency issued a draft guidance that would update the Special 510(k) Program to clarify existing policy and expand on the types of changes eligible for the program. The agency says the update includes certain changes to the indications for use and clarifies the types of technological changes that are appropriate to be reviewed as Special 510(k)s. Comments on the draft guidance will be received by the agency until 11/27.

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