Devices

Califf Hoping for LDT Legislation

Speaking at the 10/25 AdvaMed Medtech Conference, FDA commissioner Robert Califf said his preference would be for Congress to pass legislation on the regulation of laboratory-developed tests (LDTs). Asked how he would respond if Congress fails to act, Califf said, “That’s a tough question. You know, it’s not something we want to do because having a clear law passed leads to the best situation. The other option besides the law is federal rulemaking, which is always an option for FDA, but it is a very lengthy and contentious process. It would be much better for the lawmakers to come to an agreement. But we also can’t stand by.”

Reporting on the conference and Califf’s remarks, the Regulatory Affairs Professionals Society (RAPS) says FDA has long maintained that it needs to regulate certain LDTs and even issued a guidance outlining a risk-based approach as the Obama presidency drew to a close. The guidance was withdrawn during the Trump years and FDA instead issued a white paper explaining why regulating the tests is important.

FDA and AdvaMed officials say they hope some items that were removed from the user fee reauthorization bill before it was passed in late September can be included in an omnibus government spending bill in December.

“Our politicians are having a lot of trouble getting along with each other, especially right now with the election coming up,” Califf said. “We’ll be working hard to try help people understand why some of these things are important.”

Other issues Califf said are important to him include making sure FDA can quickly hire the additional staff allocated through the user fee agreements, allowing the agency to conduct remote facility inspections, and reforming the regulatory oversight of food.

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