Devices

FDA Narrows UDI Exemptions for Certain Convenience Kits

A draft guidance on “Unique Device Identification (UDI): Convenience Kits” outlines a narrower interpretation of convenience kits that are exempt from bearing UDIs on the individual components. Under FDA’s 2013 UDI final rule, devices packaged within the immediate container of a convenience kit are excepted from UDI labeling requirements if the kit bears a UDI. The draft document discusses a change in policy that limits this UDI exception to “two or more different medical devices packaged together for the convenience of the user where they are intended to remain packaged together and not replaced, substituted, repackaged, sterilized, or otherwise processed or modified before the devices are used by an end user.”

The document appears to single out medical procedure kits, which sometimes consist of hundreds of implants and reusable instruments on numerous trays configured specifically to the requirements of a surgeon. With these kits, FDA explains, “only a few of the individual implants in each kit may be selected for implantation. After the procedure, the kits are replenished with different implants, replacing those used during the procedure. The trays, including the replacement implants, the implants not chosen for surgical use, and the reusable instruments, are sterilized for subsequent configuration and use.”

The agency says it has determined that interpreting the term “convenience kit” to include such implantable devices and instruments that are provided by the labeler in sets or trays as non-sterile and repeatedly reconfigured and sterilized prior to use would be inconsistent with its purpose of allowing UDI exceptions.

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