Devices

FDA Working to Harmonize Device Quality Regs: Consultants

Cognition, a medical device consulting firm, says FDA efforts to harmonize elements of its Quality System regulations with ISO 13485:2016, the International Organization for Standardization’s updated medical device quality management standard, “reflect actions to empower domestic manufacturers in the global marketplace.” In a white paper, Cognition says the full scope of FDA harmonization efforts is yet to be defined.

“This uncertainty can be difficult for manufacturers to manage,” it says. “Taking steps now to comply with what may or may not be outdated within a few years is not a worthwhile investment of time and resources. At the same time, neglecting to be proactive in their compliance efforts could lead to remediation and other later-stage development issues that ultimately impact project timelines and result in rework.”

Of particular concern for manufacturers now, the paper says, is how FDA will approach updating and harmonizing its current requirements for design controls. “The new ISO standard is definitely influenced by FDA’s design controls, but there are areas of differentiation that could impact the future of U.S. regulation around this vital aspect of medical device development and quality management,” Cognition says. “Apart from differences in scope, language, and approach, the newest edition of ISO 13485 also has broader quality management system implications for design controls that could influence FDA’s harmonization initiatives.”

The paper lists key differences between the ISO standard and FDA design controls and suggests potential impacts of the harmonization effort on 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

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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