Devices

FDA Details Device ‘Accreditation Scheme for Conformity Assessment’

FDA has posted details of an “Accreditation Scheme for Conformity Assessment (ASCA)” pilot program that “aims to enhance the predictability of the medical device review process by reducing premarket questions in areas where current conformity activities result in inconsistent testing practices, conformance declarations, and regulatory review.” ASCA seeks to increase submission consistency, which will save FDA resources in reviewing certain testing, according to the agency. It will “promote the development and recognition of consensus standards and improve post market safety and performance evaluation due to a greater understanding of how the device was tested and evaluated.”

Under the pilot, FDA will define a “conformity assessment scheme” that will describe interactions between, and specifications for, accreditation bodies and testing labs. “Analogous to other types of third party accreditations, the scheme will outline a process for participation by accreditation bodies and testing labs and the suspension or withdrawal of poorly performing participants,” the agency says. “In order to promote transparency, we intend to publicly post information on FDA’s Web site about ASCA testing labs, including the FDA-recognized consensus standards for which they are accredited.”

FDA is still determining the standards to be included in the pilot, but it has identified some for initial consideration. As mandated by a user fee program commitment, the pilot will include a minimum of five appropriate FDA-recognized consensus standards. A related public workshop earlier this year focused on standards from the following areas:

Biological evaluation of medical devices
Basic safety and essential performance of medical electrical equipment, medical electrical systems and laboratory equipment

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