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 Updates Guidance on Mobile-Software Apps."
Following is an excerpt:
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.
