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 Mobile Medical App Guidance Faces Delay to 2013,” written by Sara Jackson.
Following is an excerpt:
New congressional action could seriously delay the Food and Drug Administration’s mobile medical app guidance.
Sen. Tom Harkin (D-Iowa) has proposed a new bill (S.3187) that, among other things, would require the FDA to conduct a full-scale report to Congress on its plans for regulating mobile medical apps. And it wouldn’t be allowed to finalized its proposed mobile apps guidance until it received the Senate’s sign off. ?…
Bradley Thompson, FDA expert with Washington, D.C.-based law firm Epstein Becker Green, hopes it won’t come to that. He and other proponents are “actively talking with Senate staff” about the FDA’s timeline, and pushing for the guidance “not to be held up,” he tells FierceMobileHealthcare. With the pace the market is growing and changing, he says, healthcare providers, app developers and others need clarity now on what the FDA expects, and what the regulatory process will be–not in late 2013.