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 "Final FDA Guidance Provides Clarification and Confusion."
Following is an excerpt:
Well, it finally happened--the most anticipated mHealth event of the year. Yesterday, the FDA released its final guidance on mobile medical applications. On the surface of it, for a 43-page document that took the regulatory agency more than two years to complete, the finished result was a bit anticlimactic. However, upon closer review, app developers looking for an FDA communication that goes beyond its July 2011 draft guidance on mobile medical apps, may not be disappointed. ...
"Basically this went from a footnote, footnote 13 in the original document, to a full six pages in the final guidance," said Bradley Merrill Thompson, general counsel for the mHealth Regulatory Coalition, speaking to FierceMobileHealthcare yesterday. "This is a wonderful development for industry because it really is clarifying what was previously confusing, and perhaps even expanding on the idea."
Still, at the same time, Thompson admitted that "an awful lot of the language in the final guidance document is new; which means it has not been publicly vetted before." He warned that "while much of it is carefully written, some of it is subject to interpretation and a bit confusing." However, Thompson reassured me that "these issues will get worked out; they don't seem to be very fundamental."
