Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice in the Washington, DC, office, was quoted in an article titled "Makers Of Research-Only Tests Must Respond To Inappropriate Use — FDA Draft Guidance."

Following is an excerpt:

Diagnostics makers can be held responsible for inappropriate, clinical use of tests labeled for investigational or research use only, if they are aware of it, FDA says in new draft guidance.

"It's the first time I've ever heard FDA say that mere knowledge of how your customer uses [a research-use-only test], if they use it for a clinical purpose, is enough" to require cutting off sales to that customer, said attorney Bradley Thompson.

Thompson predicted that labs wishing to use RUO (research use only) products clinically may simply stop discussing the specifics with manufacturers. "I think labs that want to use something clinically will really avoid talking about it to a manufacturer."

"It's the whole impression created when you market the product," Thompson said, not merely how a firm labels it.

Attorney Thompson argues that this definition is too broad. "For a long time I've been debating with FDA that RUO is a narrower concept than they're using that term to describe," he said.

"There are really two kinds of products. There are RUOs where the ultimate hope is that it will turn into an IVD. That is different from a research product that is anything you might use in research to figure out basic scientific facts."

"There is no intention of ever bringing [the latter] products to market [as] an IVD."

Overall, however, Thompson views the draft guidance as a positive for the diagnostics industry in that it levels the playing field between companies that have been trying to do the right thing and those that have pushed the envelope in marketing research-use tests.

"Now everyone's on notice," he said. "I am anticipating that FDA will go out and engage in more vigorous enforcement" with this guidance in place.

Jump to Page

Privacy Preference Center

When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. This information might be about you, your preferences or your device and is mostly used to make the site work as you expect it to. The information does not usually directly identify you, but it can give you a more personalized web experience. Because we respect your right to privacy, you can choose not to allow some types of cookies. Click on the different category headings to find out more and change our default settings. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer.

Strictly Necessary Cookies

These cookies are necessary for the website to function and cannot be switched off in our systems. They are usually only set in response to actions made by you which amount to a request for services, such as setting your privacy preferences, logging in or filling in forms. You can set your browser to block or alert you about these cookies, but some parts of the site will not then work. These cookies do not store any personally identifiable information.

Performance Cookies

These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. They help us to know which pages are the most and least popular and see how visitors move around the site. All information these cookies collect is aggregated and therefore anonymous. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance.