Devices

Location Affects FDA Device Inspections: Analysis

Attorney Bradley Thompson (Epstein, Becker & Green) says the county in which a medical device manufacturing facility is located “has a big impact on the likelihood of inspection” by FDA. Writing in the National Law Review, Thompson says his analysis did not show a relationship between FDA district offices or regions and inspection frequency.

“At the state level, we don’t really discern any trends,” he writes. “There are certainly some states like North Dakota that don’t have any hotspots. But quite honestly that’s because North Dakota has few medical device establishments to begin with.”

Thompson says he did his analysis to get beneath the numbers in FDA maps that indicate the agency tends to inspect where medical device facilities are located.

“It’s much more informative to look at the data at a county level because there’s actually quite a bit of variation county by county,” he says. “More importantly, we wanted to normalize the inspection data by the number of facilities. In other words, by looking at inspections per facility, we can get a better sense of inspection frequency in each county.”

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