Devices

CDRH ASCA 2019 Annual Report

CDRH is using the 2019 ASCA Annual Report to detail progress made during the year toward an Accreditation Scheme for Conformity Assessment (ASCA) pilot program as required under the 2017 FDA Reauthorization Act. The report says the pilot “is anticipated to augment confidence in and reliance upon Declarations of Conformity to certain FDA-recognized standards.

FDA committed to develop and start the pilot with stakeholder input by the end of FY 2020. The pilot outcome is intended to translate into greater consistency and predictability in the agency’s approach to assessing conformance to standards in medical device review by enhancing FDA’s confidence in the testing laboratories’ test methods and results.

“The need for internal FDA consultations, complete test report review, and additional information requests are anticipated to decrease,” the report says, “benefiting both FDA and manufacturers. Ultimately, we expect that the ASCA pilot will help FDA ensure safe, effective, and high-quality medical devices are available to patients.”

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