Devices

Medical Device Feedback/Meeting Guidance

FDA has published a draft guidance, Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program, with an overview of the mechanisms available to submitters to request feedback from or a meeting with FDA on potential or planned medical device IDEs, PMAs, HDEs, De Novo requests, 510(k)s, CLIA waiver by applications, dual 510(k) and CLIA waiver by applications, accessory classification requests, and certain INDs and BLAs submitted to CBER. The document says that a 2/18/14 pre-submission guidance implemented a broader Q-Submission program including pre-submissions as well as additional opportunities to engage with FDA.

As part of MDUFA 4, FDA says, industry and the agency agreed to refine the Q-Submission program with changes relating to scheduling of pre-submission meetings and a new performance goal on the timing of FDA feedback for pre-submissions. “This guidance reflects those changes and clarifies other elements of the Q-Submission program” the document says.

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