Devices

FDA to Again Try to Regulate LDTs: Attorneys

Four Sidley Austin attorneys say FDA expects to issue in August a notice of proposed rulemaking to amend agency regulations to make explicit that laboratory-developed tests (LDTs) are medical devices under the Federal Food, Drug, and Cosmetic Act. In an online post, the attorneys say the agency decided to act after Congress was unable to approve the VALID (Verifying Leading-Edge IVCT Development) Act to clarify FDA authority.

The post says that in the past the agency has faced challenges to its attempts to regulate LDTs through guidance. “Enduring questions remain about how FDA intends to regulate LDTs under the existing device statutory framework,” they say.

The attorneys also describe a voluntary FDA pilot program for certain oncology drugs that are used with in vitro diagnostic tests to assist clinicians in selecting appropriate cancer treatments for patients. They say that companies choosing to participate in the pilot may have an opportunity to more directly shape the agency’s oversight of these types of diagnostic tests and to help set the relevant performance characteristics for similar tests.

“Laboratories and companies that develop and market LDTs should take note that FDA is prioritizing oversight over LDTs, especially LDTs that it considers to be higher risk,” the authors conclude. “Companies should track these developments closely and consider their existing and developing validation and verification data. The status of FDA’s regulation of LDTs has been opaque in recent years, and FDA’s new approach is likely to be met with pushback in light of enduring questions about whether FDA’s authorities extend to LDTs.”

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