Devices

Stakeholders Want More Device Accessories Reclassified

Three medical device stakeholder groups have asked FDA to consider additional medical device accessories for reclassification into Class 1. AdvaMed said in a comment letter that it agrees with the down-classification of the devices and associated product codes listed in an FDA notice requesting comment, and believes there are additional devices currently on the market that should also be down-classified. Consistent with the intent of the FDA Reauthorization Act of 2017, the trade association writes, “we believe accessories currently on the market that fall within the product codes in the attached document should be administratively down-classified to Class 1 through this notice.”

In its letter, Cook Group suggests several additions to the FDA list along with a statement of the rationale that supports safety and effectiveness of those devices under the general control provision of the Federal Food, Drug, and Cosmetic Act.

Finally, the Orthopedic Surgical Manufacturers Association is asking the agency to revert to its previous longstanding practice and treat all manual surgical instruments provided with Class 2 or Class 3 orthopedic implant systems as Class 1 devices in accordance with their current classification designation. Alternatively, the association says, FDA should publish new classifications and associated product code descriptions for those instruments that the agency believes carry a higher risk and should be in Class 2 or 3.

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