FDA logoOn Friday, January 16, the FDA posted two draft guidance documents that outline their current thinking about low-risk devices intended for general wellness and medical device accessories. Less regulatory burden will make a huge impact on the ability of low risk devices inventors to bring product to market faster and cheaper. This blog analyses general wellness devices.  See my February 3 , 2015 blog for medical device accessories analysis.

The FDA is proposing to not enforce regulatory compliance for products that are intended to promote general wellness. In the opinion of the FDA, these devices are designed to maintain or encourage a healthy lifestyle and reduce the risk or impact of certain diseases or conditions.

To quote: “CDRH does not intend to examine low risk general wellness products to determine whether they are devices within the meaning of the FD&C Act or, if they are devices, whether they comply with the premarket review and post-market regulatory requirements for devices under the FD&C Act and implementing regulations, including, but not limited to:

• Registration and listing and premarket notification requirements (21 CFR Part 807);
• Labeling requirements (21 CFR Part 801 and 21 CFR 809.10);
• Good manufacturing practice requirements as set forth in the Quality System regulation (21 CFR Part 820); and
• Medical Device Reporting (MDR) requirements (21 CFR Part 803).”

It is important to note that the general wellness manufacturer will not be able to make any reference to the disease or condition. Examples of proper general wellness claims provided in the guidance are:

• Weight management
• Physical fitness
• Relaxation or stress managements
• Mental Acuity
• Self-esteem
• Sleep Management
• Sexual Function

In addition, the guidance provides illustrative examples of claims, as well as a list of products that would not be considered “low risk”. This list is not limited to obvious devices like lasers and invasive (penetrates or pierces skin) products. I highly recommend reading it carefully.

Also, I’d like to remind readers that there is separate guidance for software products – please refer to Mobile Device Applications guidance or read our blog.

Vesna Janic is a Director of Quality/Regulatory at StarFish Medical. Her expertise in regulatory compliance and conformance with standards guides our QA/RA team and helps clients avoid waste while gaining time to market.





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