Devices

FDA Needs Unauthorized Test Enforcement Policy: GAO

The Government Accountability Office (GAO) says FDA should develop a policy for using enforcement discretion regarding unauthorized diagnostic tests in future public health emergencies. “This policy should include the conditions under which FDA would begin and end the use of such discretion,” a GAO report says.

GAO says it was asked to review FDA’s oversight of tests for Covid-19. It found that the agency took several actions aimed at increasing the availability of Covid-19 tests in the U.S. That included granting emergency use authorizations (EUAs) for more than 400 Covid-19 tests and sample collection devices by the end of 2021.

“As of 9/30/21,” GAO says, “FDA had exercised its enforcement discretion for 370 tests. Test developers had submitted EUA requests for these tests, but FDA had not yet reviewed them. FDA officials told GAO they had concerns about the lack of review for these unauthorized tests and, as the number grew, the risks of this policy began to outweigh the benefits. Nevertheless, it was not until 11/2021 that FDA updated its Covid-19 test policy with the intention of phasing out the agency’s use of enforcement discretion and reducing the number of unauthorized tests.”

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