Devices

FDA Drops LDT Regulation, Looks to RUOs: Attorneys

Having failed to appeal a federal court decision vacating the laboratory-developed test (LDT) rule it proposed, FDA has accepted that it does not have a role in regulating such tests. That’s the view of attorneys Steven Gonzalez and Allyson Mullen (both Hyman, Phelps & McNamara) in a post on their firm’s FDA Law Blog.

The attorneys say that shortly before the agency allowed the appeal deadline to pass, it released a relatively rare Warning Letter to a manufacturer of research-use-only (RUO) reagents. “RUO-labeled reagents and materials are often used in LDTs in clinical laboratories,” they write…. “Because LDTs for clinical diagnostic use can sometimes include RUO labeled components, FDA may look to increase the scrutiny of these components as a means of tightening its control of the inputs to LDTs. We do not see the release of this Warning Letter as directly related to the LDT litigation, however…. [T]he events surrounding this particular Warning Letter preceded the LDT decision.”

Gonzalez and Mullen say the Warning Letter to Germany’s DRG Instruments said FDA had determined that the company’s RUO-labeled assay was intended for clinical diagnostic use, citing statements on the firm’s Web site and labeling, and records that showed distribution to clinical laboratories that did not perform any research.

“A striking detail in the Warning Letter was that FDA found it did not matter that the company had certification letters on record that showed at least some of their customers were aware that the products should be used for research purposes, because FDA’s own ‘review of these customers’ Web sites strongly suggests that these customers are engaged in clinical diagnostic testing,’” the post says.

The attorneys conclude they do not doubt that as the door to regulating LDTs directly has closed, absent new legislation, FDA is likely to look for a new door to open. “Greater scrutiny of RUO products and those companies that manufacture them could be one of those doors,” they say.

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