Devices

FDA Tightening ‘Research Use Only’ Tests: Lawyers

A 4/2 Warning Letter to Agena Bioscience saying the firm’s iPLEX HS Colon Panel is misbranded and adulterated because it is labeled for research use only (RUO) but reportedly is promoted for human clinical purposes signals a tightening of FDA’s enforcement of RUO labels. That’s the analysis of three SheppardMullin attorneys in an online FDA Law Blog post.

The attorneys write that since FDA has issued a relatively limited amount of guidance on the development and distribution of such products, the Warning Letter “adds important, and impactful, clarification to FDA’s policy on the issue.” Ultimately, they say, the letter is part of a larger agency movement to focus on diagnostic products that have historically been exempt from regulatory oversight.

According to the post, FDA made a statement by issuing a Warning Letter rather than an Untitled Letter or other less severe form of communication. Also, it says, the agency cited an extensive list of alleged marketing violations, including product sales to clinical customers, which may or may not have research capabilities, and the use of relatively broad promotional language.

“Ultimately, the Warning Letter presents more questions than answers,” the attorneys say. They question whether Agena will challenge the letter and whether other manufacturers will request advisory opinions to clarify the parameters in the development and distribution of RUO-labeled products. They also question whether FDA is placing the onus on manufacturers to determine the operations of laboratory customers before soliciting business and how many resources would need to be expended to make such a determination.

“While manufacturers of RUO-labeled diagnostic devices wait on answers to these and other questions,” the post concludes, “it may be prudent to begin reviewing customer lists and promotional claims to ensure that marketing activities cannot be construed as potentially condoning clinical use.”

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