Devices

FDA Proposes Use of ISO Medical Device Standard

FDA is proposing to incorporate by reference in the Quality Management System the International Organization for Standardization ISO 13485, approved in 2016. A Federal Register notice says FDA has historically recognized the benefits of harmonization with other regulatory authorities and over time has acted to promote consistency with its regulatory counterparts.

“Through this proposed rulemaking,” it says, “FDA intends to converge its requirements with quality management system requirements used by other regulatory authorities.”

A harmonized QSR effort has been in the works for several years. The release of the proposal was delayed by Covid-19. On 12/9/21, CDRH Office of Product Evaluation and Quality director William Maisel told a virtual Food and Drug Law Institute compliance update that the proposed rule would be released “very soon” and that it would help harmonize domestic and international requirements, reducing compliance and bookkeeping burdens on device manufacturers.

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