Devices

Don’t Exempt Drug Assays from 510(k): Sharfstein

A comment letter signed by former FDA principal deputy commissioner Joshua Sharfstein (now a professor at Johns Hopkins University) and five other medical school professors or researchers says that drug testing assays that are Class 2 medical devices and used for employment or insurance purposes should not be permitted to come to market without first submitting 510(k) premarket notification, including disclosure of device technological characteristics. The letter says the assays should be removed from proposed exemptions from the FDA premarket notification list because they fail to meet two specified criteria for an exemption:

Changes will be readily detectable. The letter says that for drug testing assays, a crucial technical specification is the cutoff value for a positive drug test that is measured in nanograms, a unit that does not meet FDA device exemption guidelines of changes needing to be “readily detectable by users by visual examination … or other routine testing.”
Changes will not increase the risk of injury or incorrect diagnosis. A false positive result can cause significant harm in tests used for employment or insurance purposes, the comment letter says.

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