Devices

Use of Voluntary Consensus Standards Guidance Explained

A 10/25 CDRH Webinar explained a recent guidance on appropriate use of voluntary consensus standards in premarket submissions for medical devices. During the program, CDRH director of the standards and conformity assessment program Scott Colburn reviewed the evolution of the guidance from its 2014 draft to changes that were incorporated in the final version issued 9/14.

“The take-home messages from stakeholders who commented on the draft guidance were for the agency to follow least burdensome principles when requesting test reports; provide consistency across the Center with regards to data requests, test summaries, or complete test reports; and to provide increased transparency about how standards are applied across review offices and divisions,” Colburn said.

He said the final guidance incorporated the 21^st Century Cures Act and clarified that deviations may be made to a standard but not within the context of a Declaration of Conformity. FDA also clarified its position on promissory statements in that if a company chooses to rely on a recognized standard or guidance for any part of a device, design, or testing, it may include either a Declaration of Conformity or a statement that testing will be conducted and meets specified acceptance criteria before the device is marketed.

“Because the Declaration of Conformity is based on results from testing,” Colburn said, “we believe you cannot properly submit a Declaration of Conformity until you have completed the testing the standard describes.”

The agency adopted ISO/IEC 17050-1 and -2 that clarifies the content of a Declaration of Conformity and the accompanied supporting documentation that underpins the extent of the conformity and how it was assessed, Colburn explained. Form 3654 was eliminated because its elements are addressed by the Declaration of Conformity.

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