The FDA's Center for Devices and Radiological Health (CDRH) is seeking public comment on draft guidance it released earlier this week that lays out the agency's compliance policy for certain devices consumers use to monitor and/or promote general health and wellness.
The 11-page draft guidance document(www.fda.gov) was issued on Jan. 20 and focuses on "low-risk devices that promote a healthy lifestyle," which include exercise equipment, audio recordings, mobile apps, video games and other products typically available from retailers.
Specifically, the scope of the guidance is limited to "general wellness products" that either:
- are intended to maintain and encourage healthy activity or
- help reduce the risk or impact of chronic diseases or conditions.
CDRH defines the first category as products that relate to weight management, physical fitness, relaxation or stress management, mental acuity, self-esteem, sleep management or sexual function "that do not make any reference to diseases or conditions."
The agency defines products in the second category as being intended to promote, track and/or encourage choice(s) as part of a healthy lifestyle, which may help reduce the risk of, or allow people to live well with, chronic diseases or conditions.
This policy doesn't include high-risk products that present inherent risks to users' safety, which CDRH defines as "invasive, involving an intervention or technology that may pose a risk to a user's safety if device controls are not applied (such as risks from lasers, radiation exposure or implants), raising novel questions of usability or raising questions of biocompatibility."
The AAFP weighed in on this general topic last July, when it provided comments on a health IT report(www.fda.gov)
developed by the FDA in consultation with the Office of the National Coordinator for Health Information Technology and the Federal Communications Commission. The report outlined a strategy for how the federal government -- with input from health care and health IT stakeholders -- should move forward as it develops a risk-based regulatory framework for health IT.
Steven Waldren, M.D., director of the AAFP's Alliance for eHealth Innovation, said at the time that ensuring a balance between safety and innovation would require separating software products that have a low risk of harm to patients from those that have a high risk, and then focusing safety efforts on those high-risk products.
"Overregulation of software products that carry a low risk will only serve to inhibit and slow innovation at the very time the health care industry needs more proven health IT resources to flow into the market," said Waldren.
The CDRH is seeking comments on the current draft guidance, especially on any additions or notes about the current list of product uses related to encouraging healthy behavior. Comments may be submitted electronically(www.regulations.gov) until April 12.