Devices

Guidance on Device Pre-Submission Meetings

FDA has posted a final guidance entitled “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.” The document includes minor procedural updates and clarifications related to scheduling pre-submission meetings for investigational medical devices. Under the Medical Device User Fee Amendments of 2022, new performance goals were outlined regarding performance goals for such meetings.

The agency also committed to issuing a draft guidance to include additional information to assist applicants and review staff in identifying the circumstances in which an applicant’s question is most appropriate for informal communication instead of a Pre- Submission. The current updated guidance provides procedural changes and clarifications while the draft guidance is being developed, FDA says. They include:

Examples of common review topics and questions for a Pre-Sub
Timing considerations for multiple submissions
Administrative content to include in Q-Subs to facilitate FDA review
Q-Sub meeting minutes format and submission process
Existing mechanisms to obtain FDA feedback outside of the Q-Sub Program.

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