Bradley Merrill Thompson Quoted in Article About FDA Guidance on Research-Use Tests

The Gray Sheet

Bradley Merrill Thompson, a Member of the Health Care and Life Sciences practice in the Washington, DC, office, was quoted in an article titled "FDA To Issue Guidance On Research-Use Tests This Month."

Following is an excerpt:

FDA's diagnostics office hopes to issue draft guidance this month for tests that are marketed for research or investigational uses only.

Thompson told AMDM meeting attendees that FDA could not prosecute a company based solely on the inappropriate use of a product unless they could show that the manufacturer intended it to be used that way.

But even a company's sales pitches, promotional websites or instructions for use could be used against them, noted Thompson.

"Certain instructions which seem relatively benign to some people might be considered by FDA to be implied clinical claims," Thompson said. "This is a very delicate analysis."

Thompson recommended that firms consider making customers sign a certificate that they understand and agree to use the tests in the appropriate, limited ways.