Devices

CDRH Outlines Requests for Alternative UDI Approaches

CDRH has updated its Web page on requests for an exception to use an alternative approach to meet requirements under the agency’s Unique Device Identifier (UDI) rule. According to the agency, a device labeler may submit a request for an exception from or alternative to the requirement for the label of a device to bear a UDI or other UDI requirement under 21 CFR 801 Subpart B (Labeling Requirements for Unique Device Identification) for a specified device or a specified type of device. “In response to labeler requests or on our own initiative, the FDA may grant an exception or alternative if an exception is appropriate because the requirements of 21 CFR 801 Subpart B are not technologically feasible, or that an alternative would provide for more accurate, precise, or rapid device identification than the requirements of 21 CFR 801 Subpart B or would better ensure the safety or effectiveness of the device that would be subject to the alternative,” it says. “If the FDA grants an exception or alternative, we may include any safeguards or conditions deemed appropriate to ensure the adequate identification of the device through its distribution and use.” The agency is making its decisions on labeler requests for exceptions and alternatives available at “FDA Decisions.”

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