Devices

Increase FDA Oversight of Lab-developed Tests: Pew

A new Pew Charitable Trusts survey finds that most participants expressed support for reform that would increase FDA’s oversight of lab-developed tests (LDTs). The Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2021 is a “solid foundation to achieve this goal,” Pew said, adding that Congress should work with other stakeholders to address outstanding issues and pass legislation that ensures all diagnostic tests are safe, accurate, and reliable.

Pew also says its survey found that about 10% of those who have received a result from an in vitro diagnostic reported receiving an inaccurate result, “which may mean that nearly 20 million adults in the U.S. have received inaccurate test results. More than half of those who reported inaccurate results discovered them either through a doctor or medical professional, or because they experienced an illness or symptom that contradicted the test results.”

While most survey participants supported FDA having oversight over all diagnostic tests, some were concerned that increased regulatory hurdles might limit patient choice. However, almost all participants supported specific policies that would improve oversight, including:

Requiring test developers to register their products with FDA.
Requiring test developers to provide FDA with test performance information.
Requiring test developers to report adverse events.
Allowing FDA to request data from test developers as needed.
Providing FDA with the authority to remove unsafe or inaccurate tests from the market.

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