Bradley Merrill Thompson Quoted in “FDA Lightens Regulations on Medical Device Data Systems, Mobile Apps”Health Data Management February 9, 2015
Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Health Data Management, in “FDA Lightens Regulations on Medical Device Data Systems, Mobile Apps,” by Greg Goth.
Following is an excerpt:
According to Bradley Merrill Thompson, an attorney at Washington, D.C.-based law firm Epstein Becker Green who counsels medical device companies on regulatory issues, the FDA is “sticking to its word” by working to down classify or altogether exempt low-risk software-based technologies. In June 2014, FDA issued draft guidance explaining that its regulatory oversight of health information technology products is now focused on devices that pose higher risk to patients than MDDS.
“This type of software used to be regulated as an accessory, so if the software was used, for example, to transfer data out of the blood glucose meter, it was class II. Then, in 2011, FDA put such software uniformly in class I regardless of the medical device it accessorized,” Thompson tells Health Data Management. “That was a huge step, because some of the software connected with class III devices.”