FDA Sends Mixed Messages on Medical Device Data Systems

The Food and Drug Administration is sending mixed messages regarding the recent release of final guidance stating that it does not intend to enforce compliance with regulatory controls for medical device data systems (MDDS) and whether product manufacturers should in fact comply.

MDDS is hardware or software that transfers, stores, converts formats, and displays medical device data from a variety of other devices, including glucose meters, blood pressure cuffs, and weight scales. Last month, the FDA announced its intention not to enforce compliance with the regulatory requirements that apply to MDDS, including registration and listing, premarket review, postmarket reporting, and quality system regulation for manufacturers of these types of devices.

However, instead of clarifying its decision, the regulatory agency seems to have clouded the issue somewhat. Speaking in an FDA webinar last week intended to help device manufacturers better understand the policies described in the guidance, a senior FDA official likened the regulatory agency’s decision on MDDS to police discretion in not enforcing laws for drivers that exceed the speed limit.

“We’re not going to apply active enforcement discretion,” said Sugato De, senior policy advisor for the Office of the Director of the FDA’s Center for Devices and Radiological Health (CDRH). “This is kind of analogous to maybe a local police department saying, we’re not going to issue a ticket for going five miles over the speed limit. The law still says you can’t go over the speed limit.”

De advised device manufacturers that “you, as a company, in this case as the driver, you have to make the decision if you are going to go over the speed limit or not.” Building on his analogy equating police discretion in issuing speeding tickets with the FDA’s enforcement discretion regarding MDDS, he continued, saying: “The department is just saying, ‘we won’t give you a ticket.’ It’s still your decision. And it’s probably in your best interest to do it. It’s just we’re not going to, you know, actively apply enforcement discretion.”

But, a member of the webinar audience accused the FDA of “talking out of both sides of its mouth” by on the one hand saying that “this stuff applies” and on the other hand offering that “we’re not going to come out and make sure that you’re doing it.” He also commented that the FDA’s final guidance on MDDS “doesn’t seem to alleviate anything that we need to be doing on this side, if we want to make sure that we’re managing our risk.”

In reply, Bakul Patel, FDA associate director for digital health in CDRH, said: “We expect you to manage your risk as you would normally do in other ways or other types—other reasons. All we’re saying is from a regulatory perspective, and our compliance perspective, we would be not focusing in that area.”