Devices

Comments on Physiologic Closed-Loop Guidance

Medtronic says it appreciates FDA efforts to establish appropriate considerations for premarket submissions for medical devices with physiologic closed-loop control technology. Commenting on the agency’s 12/23/21 draft guidance on the topic, the company says it also appreciates the agency’s recognition of the value of computational models as an alternative or to supplement bench, animal, and/or clinical studies.

The company further says it appreciates that the draft uses already developed standards and says the relevant requirements applicable to physiologic closed-loop controlled devices should be aligned as closely as possible with IEC 60601-1-10. “Medtronic is concerned that deviation from the IEC standard will add unnecessary burden beyond what is required by IEC 60601-1-10 and cause inconsistency with the standard without improving patient safety or device effectiveness,” the comment says.

The BD comment letter gives specific line-by-line comments, including a statement that while the draft provides a good initial list of devices that are applicable, it could be improved with additional examples that also are relevant to the proposal.

Line-by-line technical comments also came from Tandem Diabetes Care.

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

Read more

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