Devices

FDA, CMS Reiterate Need for FDA Test Oversight

In a joint 1/18 statement, CDRH director Jeff Shuren and Centers for Medicare & Medicaid Services (CMS) acting chief medical officer and acting director of the Center for Clinical Standards and Quality Dora Hughes say both agencies support an FDA 10/2023 proposed rulemaking to regulate laboratory-developed tests. “Both CMS and FDA believe that patients and their doctors need to know that LDTs are valid,” the statement says. “FDA and CMS both provide oversight to help assure the accuracy of test results, however, they have different roles. CMS regulates laboratories that perform testing in individuals in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA) of 1988 by establishing quality standards for all laboratory testing to help ensure the accuracy, reliability, and timeliness of patient test results.”

While some stakeholders have suggested that LDT concerns should be addressed through an expansion of CLIA, Shuren and Hughes say that is not the answer since CMS does not have the expertise to assure that tests work, while FDA does. “Moreover,” they say, “establishing a duplicative system for the oversight of tests by expanding CLIA would create more government bureaucracy and inconsistencies. That makes no sense.”

Shuren and Hughes conclude that patients and providers need to have confidence that laboratory tests work. “We believe the complementary FDA and CMS frameworks are both critical to assuring patients can rely on the clinical accuracy of their test results,” they say.

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