Devices

CDRH Adds Device Sterilization Standards

CDRH is announcing new steps to improve medical device sterilization. For one, the Center has updated its Recognized Consensus Standards database to include the complete recognition of one sterilization standard (ISO 22441:2022). The new standard, Sterilization of Health Care Products — Low Temperature Vaporized Hydrogen Peroxide — Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices, supports use of the converted gas as an alternative sterilization method.

The other step is CDRH’s recognition of two “Technical Information Reports” associated with medical device sterilization — AAMI TIR 17:2017/(R)2020 Compatibility of Materials Subjected to Sterilization and AAMI TIR104:2022 Guidance on Transferring Health Care Products Between Radiation Sterilization Sources.

“CDRH remains committed to encouraging novel ways to sterilize medical devices while reducing adverse impacts on the environment and public health and to developing solutions that avert potential shortages of devices that the American public relies upon," Center Office of Strategic Partnerships and Technology Innovation director Suzanne Schwartz is quoted in a release announcing the new standards.

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