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 Guidance Regulates Device, Software Changes,” by Greg Slabodkin.
Following is an excerpt:
Bradley Merrill Thompson, an attorney at the Washington, DC-based law firm of Epstein Becker Green who counsels medical device companies on regulatory issues, praised the agency for updating its recommendations for the industry.
“This guidance represents a very important—and previously missing—piece to the regulatory puzzle,” Thompson says. “The FDA has started to clarify when software such as mobile apps is regulated, but they left open the question of when changes to those apps that are regulated prompt the requirement of a new 510(k). This guidance finally tackles that issue, and it does so for all software, including that which is embedded in medical devices, that which is an accessory to a medical device, and that which functions as a stand-alone medical device. We have been sorely in need of this guidance for years, and are delighted to see it.”