Devices

AdvaMed Faults FDA on ‘Safety’ 510(k) Guidances

AdvaMed is raising issues with FDA’s 9/2023 issuance of three “impactful and cross-cutting draft guidance documents related to the 510(k) program.” In its comment on the CDRH FY 2024 proposed guidance development document, the association notes that FDA said the guidances were developed in response to its 2018 Medical Device Safety Plan. AdvaMed says it and other stakeholders submitted comments on the plan.

“In the four-and-a-half years since comments were submitted for this request,” the letter says, “CDRH had not provided an update or response. Consequently, it came as a surprise when FDA issued the three draft guidance documents and stated that they are related to its 510(k)-modernization initiative. Further, two of the draft guidance documents covered topics that were outside the scope of CDRH’s questions in its 2019 call for comment.”

The letter says that since the three drafts were issued at the same time and with the same comment deadlines, were issued without any advance notice, and greatly affect the medical device industry, AdvaMed and other organizations asked for extensions to provide sufficient time to review the comments and prepare comments. “Despite the numerous requests and the broad support for extension, CDRH declined the requests,” the letter says.

The association asks FDA to provide an update on the next steps and associated timing for the three drafts. It also asks that CDRH give advance public notice of any other guidances and initiatives it intends to issue or launch related to the 2018 action plan.

The letter also contains AdvaMed’s comments on the CDRH FY 24 guidance A List and B List, noting that the three 510(k) guidances were not on the FY 2023 list and are missing from the FY 2024 list.

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