Bradley Merrill Thompson Quoted in “Simplify Mobile Device Classification”Health IT Outcomes April 2, 2014
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 "Simplify Mobile Device Classification."
Following is an excerpt:
The FDA released its wireless device guidelines in September focusing on security, maintenance, and monitoring. Now, it has proposed updates to amend its regulations governing classification and reclassification of medical devices to conform to provisions in the FDA Safety and Innovation Act (FDASIA). ?...
"This proposed rule is a very long anticipated and much needed improvement in the classification and reclassification process," Bradley Merrill Thompson, general counsel for the mHealth Regulatory Coalition, told Health Data Management. "The classification process acts as a sort of gateway to FDA regulation, dictating for a specific, defined category of medical device the regulatory requirements that apply. FDA is supposed to develop classifications for each new type of medical technology so the public knows the associated regulatory requirements. Unfortunately, FDA has fallen behind in developing new classification regulations because creating the classifications takes so darn long and involves an almost endless number of legal hoops the agency has to jump through."