FDA draft guidance tackles regulation of general wellness devices, medical device accessories

Draft guidance documents published Friday morning by the U.S. Food and Drug Administration, in compliance with actions outlined in its FDASIA Health IT Report, propose both to regulate medical device accessories based on risks they present when used as intended with their parent devices and not regulate products intended only for general wellness.

For the former guidance, the FDA stresses that some device accessories can have lower risk profiles than their parent devices, which would warrant regulation in a lower class. "For example, an accessory to a Class III parent device may pose lower risk that could be mitigated through general controls or general and special controls, and thus could be regulated as Class I or Class II," the guidance says. It also serves to encourage device makers to use the de novo classification process "to request risk-based classifications of accessories of a new type," according to the FDA.

This guidance also clarifies what the FDA deems accessories. Items intended for use with one or more parent devices, as well as items "intended to support, supplement, and/or augment the performance of one or more parent devices" are viewed as accessories in the eyes of the FDA.

Epstein Becker Green health attorney Brad Thompson, in comments to FierceHealthIT, says this guidance doesn't go far enough and instead of solving current problems, suggests that the industry solve them itself.

Thompson (pictured) says comments filed last spring to the FDA by the mHealth Regulatory Coalition (MRC)--which he represents--asked for clarification that general purpose hardware and software sold with medical software preloaded was not an accessory. MRC also called on the FDA to "amplify" on how it determines whether an item is an accessory that is part of a system. The agency failed to address both, according to Thompson.

Additionally, Thompson says, MRC wanted to ensure that interoperability claims didn't automatically lead to characterization as a medical device accessory; it also wanted FDA to reveal how it regulates claims associated with accessories, and the required validation by the accessory product manufacturer. Those requests also were not addressed.

"The crux of the biscuit is that we need them to solve this problem of overregulation," Thompson says. "We proposed to the FDA that they use guidance to develop categories of accessories that would be unregulated through enforcement discretion, to be followed up by rulemaking through which FDA would formally declassify these devices. ... FDA's response in a nutshell is 'fine; but you guys in the industry need to be the ones to specifically pursue these reclassifications,' via de novo submissions."

Still, Thompson believes there are some positive takeaways from this guidance. For instance, he says, the FDA's recognition that the risks of parent devices are not automatically "imputed" to accessories is key.

For the latter guidance, the FDA says it won't examine low-risk general wellness products to determine whether they are devices within the meaning of the Federal Food, Drug, and Cosmetic Act. In particular, it divides such general wellness products into two categories:

  1. Those devices that do not make any reference to diseases or conditions, such as weight or sleep management devices, or those that pertain to stress management, to name a few
  2. Those devices that either may help to reduce the risk of or may help living well with certain chronic diseases or conditions

Thompson is more pleased with this guidance.

"FDA truly listened to the public in crafting this guidance," Thompson says. "We said FDA should not be too conservative here, and should not claim jurisdiction over every product that identifies a disease, and seeks to help people avoid it or live with it, so long as there is widely accepted evidence that a healthy lifestyle can help. ... That's exactly what FDA proposes to do. No longer does the mere mention of a disease in promotional materials mean that FDA may regulate it. FDA has chosen to draw a very common sense line that avoids regulating products that help people manage common chronic diseases."

To learn more:
- here's the device accessories guidance (.pdf)
- check out the general wellness guidance (.pdf)