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 titled "Health IT Stakeholders Call for New FDA Regulatory Framework, Enforcement."
Following is an excerpt:
Health information technology stakeholders questioned whether FDA's existing device regulatory framework is viable for overseeing the growing industry sector. HHS and FDA officials, however, said they are confident that they will be able to properly regulate the devices using existing authorities and will focus closely on creating consistent standards that developers will have to meet before their products are approved. ...
Bradley Merrill Thompson, general counsel for the mHealth Regulatory Coalition, said he did not believe FDA regulations were slowing innovation. However, the agency is moving too slowly on guidance and taking enforcement actions against companies marketing mobile applications that should be regulated as medical devices.
"I have actually never seen FDA be more hospitable to technology than they are right now, and that's good news," he said. "The bad news is they've actually taken it too far, in my opinion. They have not gone after companies that are blatantly over the line."
Thompson said FDA enforcement actions, like warning letters, would draw clear lines about the rules companies need to follow. He said the agency should further clarify how it will distinguish between applications that fall under the definition of a medical device and those that would be considered healthy living or wellness tools. FDA has said that it will not regulate wellness applications that measure the number of steps a person takes, for example. But Thompson said the agency did not address which claims the manufacturers of such devices would be allowed to make.
Companies would like to know if touting health benefits like an enhanced ability to manage diabetes or other conditions would cause a wellness application to fall under FDA's definition for a medical device, he said, adding that the issue is unlikely to be addressed in the final guidance since it was not included in the draft. However, the issue could be part of health IT work group discussions and included in future FDA guidance on the issue, said Thompson, who is a member of the FDASIA work group.
"I want them to get the guidance that they have out," he said. "I don't want them to hold it up for this issue. But I want them to start tackling this issue and do it as quickly as they can. I am concerned. Obviously, all of these things are taking too long, so I am concerned about the speed of their policy-making generally."
