Devices

Is FDA Going After RUO Diagnostics?

The issuance by FDA of two Warning Letters to manufacturers of diagnostic products labeled for research use only (RUO) within three months may be a coincidence or may signal a new FDA enforcement emphasis. That’s the view of attorneys Dominick DiSabatino and Audrey Mercer (SheppardMullin) in their firm’s FDA Law Update.

The letters to Agena Bioscience and DRG Instruments GmbH said the firms’ products were inappropriately labeled RUO based on evidence in the agency’s view that the products were intended for clinical use, the attorneys write.

DiSabatino and Mercer say FDA cited these two points in the DRG letter as evidence that the product was intended for clinical use:

distribution records showing that DRG sold the product to “companies in the business of performing clinical analysis” with “no indication these companies also conduct research” and
claims on the company Web site that the product may be appropriate for clinical use.

The attorneys say FDA reached its conclusion despite certification letters from the purchasing companies acknowledging that the product was to be used for research purposes only.

The post says that while the DRG Warning Letter may have been a surprise given the new administration’s preference for deregulating drugs and medical devices generally, it may be part of a larger scheme to retain at least some patient safety assurances for a smaller subset of exempt diagnostics in light of its recent decision to back away from claiming oversight over laboratory-developed tests (LDTs).

“It remains to be seen whether the Warning Letter indicates an intention by the new administration to keep a closer eye on the regulatory carve-out for RUO products and/or components, despite its decision not to regulate one of the most significant policy carve-outs (LDTs), or whether the Warning Letter will ultimately be an outlier like the Agena Warning Letter,” the post concludes.

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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