Devices

AdvaMed Seeks Examples of Low-risk Manufacturing Site Changes

Advanced Medical Technology Association (AdvaMed) says FDA needs to provide more input on device manufacturing site change submissions. In just-posted comments on an FDA draft guidance on “Manufacturing Site Change Supplements: Content and Submission,” the group says more details are needed on the types of manufacturing site changes that would not affect the safety and effectiveness of the device because these could be reported to the agency in PMA periodic report or 30-Day Notice filings.

AdvaMed says that the guidance notes that a PMA supplement must be submitted for review and approval before making a change that affects the device’s safety or effectiveness, unless such change is a modification in a manufacturing procedure or method of manufacture, which would be eligible for a 30-day notice. However, it says, no specific guidance is given for manufacturing site changes that may be implemented without a PMA supplement. “Provide some examples of possible cases that might not affect safety and effectiveness,” AdvaMed says. “For example, contract manufacturing site changes for low-risk accessories approved under a PMA may not affect the safety or effectiveness of a device.”

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