Devices

Is FDA Lengthening Warning Letter Response Time?

Warning Letters sent recently by FDA to two medical device companies instructed the firms to respond within 30 days, rather than the typical 15 days. Three Hyman, Phelps & McNamara attorneys write in their firm’s FDA Law Blog that their review of some 200 Warning Letters issued by CDRH over the past five years indicated that only these two were given more than 15 days in which to respond.

They note that the 15-day response period is not a strict regulatory requirement and thus the agency is not acting contrary to its own procedures, although it is deviating from its standard practice.

What’s not known, they say, is whether these two instances were a mistake or signal a change in practice. “On the one hand,” they write, “the Regulatory Procedures Manual details a rigorous and structured process for Warning Letter submission and review. On the other hand, like many government agencies, FDA has faced significant operational upheaval since January, including reductions in force (RIF) and shifting internal expectations. Many senior leaders and support staff in FDA’s inspection programs have departed over the past year, either by choice or as part of a RIF, with whispers (or shouts) of a draining morale.”

The attorneys also point out that FDA recently announced plans to merge all of its medical product and clinical research inspectorates, transitioning inspectors from specialized roles to generalized “medical product” inspections, and reversing a 2017 “program alignment” initiative that had ensured inspectors were experts in specific commodities.

The post concludes that the writers will continue to track response time variations and for now, do not expect to see widespread use of the 30-day Warning Letter response time.

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