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 "FDA's Revised IVD Guide Focuses on 'Totality of the Circumstances.'"

Following is an excerpt:

FDA's revised guidance on in vitro diagnostics labeled as research use only (RUO) or investigational use only (IUO) addresses previous industry concerns that manufacturers would have to police the use of their tests, giving them a "well-deserved sigh of relief," according to one industry source. The updated document instead focuses on the "totality of the circumstances" surrounding the use of the products to ensure they are not being used for clinical diagnostic purposes.

In response to FDA's 2011 draft guidance, industry argued that manufacturers would have to police whether their products are being used for unapproved diagnostic purposes. Last week's updated document shows that the agency will look at the circumstances surrounding the sale and distribution of the product, including labeling and marketing. ...

"What they're saying is 'We'll look at everything you do,'" said Bradley Merrill Thompson, an attorney at Epstein Becker Green. Combined with a recent warning letter where FDA told a popular direct-to-consumer genetic testing company that its products are unapproved medical devices, the guidance shows the agency is ready to take enforcement action against diagnostic companies. However, this enforcement is likely to be strategic, he said.The Food and Drug Administration, in an attempt to get its arms around the rapidly growing field of medical mobile software, on Monday published a guidance document for companies and entrepreneurs explaining what products it plans to scrutinize carefully and which ones it plans to largely leave alone. ...

Bradley Merrill Thompson, a lawyer with Epstein, Becker & Green who represents medical-device companies, called the FDA's document "a huge step forward" and commended the agency for making clear precisely what it plans to do.

"They took the ambiguous area and made it much more spelled out," he said. "The usual situation with FDA is a dozen or so institutions file comments, and FDA changes a few words before finalizing the guidance document. In this case, FDA made massive changes." ...

Mr. Thompson said such regulation will help larger companies decide whether to jump into this field. "A lot of companies that wanted to do things the right way were sitting on the sidelines doing nothing," he said.

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