Devices

FDA May Not be Ready for LDT Rule: Attorney

Although the revised FDA unified agenda shows that a final rule on laboratory-developed tests may be published in 4/2024, attorney Allyson Mullen (Hyman, Phelps & McNamara) questions whether the agency can be ready by then. Writing in her firm’s FDA Law Blog, Mullen cites the time FDA will need to respond to the thousands of comments that were submitted on the draft rule and the number of new hires that would be needed to process the greatly expanded workload the rule would bring.

She notes that during a 10/31 Webinar discussing the proposed rule, stakeholders sought clarity from FDA officials on the agency’s plan to address the resource gap. The response covered two potential solutions, she says, (1) enhancing the existing third-party 510(k) program and (2) resolving resource issues during the MDUFA 6 negotiation process. “Neither of these proposed approaches can be expected to adequately address the anticipated volume of submissions,” Mullen declares…. “Given the acknowledged and ongoing recruitment and retention challenges, FDA’s reference to MDUFA 6 amounts to nothing more than ‘kicking the can down the road,’ rather than a meaningful plan to ensure adequate resources.”

According to Mullen, the bottom line is that without far better resource planning, this massive regulatory undertaking is going to be a disaster for all stakeholders, including FDA, industry, healthcare systems, providers, and patients. She says her firm’s comments on the draft proposal recommended that FDA not finalize the proposed regulation.

“If it does,” she concludes, “instead of requiring submissions and then hoping to obtain resources and the necessary congressional authorizations, FDA should have a clear plan for obtaining the required resources. The failure to do so is likely to result in chaos for all diagnostic products.”

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

Read more

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