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 agencys decision on MDDS to police discretion in not enforcing laws for drivers that exceed the speed limit.
Were not going to apply active enforcement discretion, said Sugato De, senior policy advisor for the Office of the Director of the FDAs Center for Devices and Radiological Health (CDRH). This is kind of analogous to maybe a local police department saying, were not going to issue a ticket for going five miles over the speed limit. The law still says you cant 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 FDAs enforcement discretion regarding MDDS, he continued, saying: The department is just saying, we wont give you a ticket. Its still your decision. And its probably in your best interest to do it. Its just were 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 were not going to come out and make sure that youre doing it. He also commented that the FDAs final guidance on MDDS doesnt seem to alleviate anything that we need to be doing on this side, if we want to make sure that were 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 typesother reasons. All were saying is from a regulatory perspective, and our compliance perspective, we would be not focusing in that area.
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