Devices

FDA Won’t Enforce ID Submission for Some Class 1 Devices

FDA has issued a draft guidance, Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices, to revise a section of a 7/1/20 guidance on compliance dates for Class 1 and unclassified devices. The draft says certain Class 1 devices are considered by the agency to be consumer health devices for which it does not intend to enforce Global Unique Device Identification Database (GUDID) submission requirements. The document also explains how a labeler of a Class 1 device can determine if their device is within the scope of the compliance policy.

“With respect to Class 1 devices that are considered consumer health products,” the draft says, “FDA believes that the entry of universal device identification (UDI) data into GUDID, especially given the frequent changes to the universal product codes serving as the UDIs for these devices, is burdensome to stakeholders.”

The draft says Class 1 devices that the agency does not consider to be consumer health products may pose greater risks to public health and thus are not covered by the compliance policy.

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