Devices

Final QS Rule for International Harmonization

FDA has published a final rule, Quality Management System Regulation Final Rule, to amend the current Quality System Regulation good manufacturing practice (CGMP) requirements to harmonize with an international standard. The document will take effect on 2/2/26, giving medical device manufacturers and importers two years to modify their quality systems to meet the final rule requirements. Until then, FDA says, manufacturers are required to comply with the existing Quality System Regulation.

The rule says it is harmonizing requirements by incorporating by reference the 2016 edition of ISO (International Organization for Standardization) 13485, an international standard specific for device quality management systems that is used by other regulatory authorities in other countries. It also establishes additional requirements and makes conforming edits to clarify the device CGMP requirements for such products.

“This action will continue our efforts to align our regulatory framework with that used by regulatory authorities in other jurisdictions to promote consistency in the regulation of devices and provide timelier introduction of safe, effective, high-quality devices for patients,” FDA says.

CDRH director Jeffrey Shuren says that “by harmonizing key areas of a medical device manufacturer’s quality management system with the international standard, FDA can better leverage inspections conducted for other countries, while streamlining actions device manufacturers must take to meet requirements by multiple regulatory authorities.”

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