Devices

FDA Multifunctional Device Guidance Explained

An FDA 7/29 final guidance on the regulation of medical devices with multiple functions is largely similar to an earlier draft but with further clarification about the agency’s expectations for the device manufacturer risk assessment processes, including new language on assessing cybersecurity risks associated with non-device functions, according to an online FDA Regulatory Alert prepared by Ropes & Gray attorneys. They write that the final guidance also provides additional information on the agency’s expectations for premarket submissions for multiple function device products, including information on labeling claims addressing non-device functions. And it includes a new flow chart illustrating how FDA will assess the impact of non-device functions on device functions when reviewing premarket submissions, and a new discussion of modifications to previously approved or cleared multiple function device products.

“Companies that seek to develop multiple function device products should consider designing their product with a clear demarcation between the device and other functions and ensuring that they have robust cybersecurity procedures in place,” the attorneys conclude. “Additionally, companies should carefully document any impact of the “other function” on the safety and effectiveness of the device function. Even if FDA does not require disclosure of all positive impacts in the premarket submission, this information will be important to ensure quality compliance.”

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