On January 20, 2015, the Food and Drug Administration (“FDA”) published two draft guidance documents that revealed its way of thinking on the regulation of low risk general wellness products and regulation of medical device accessories.
Broadly speaking, the proposed guidance indicates that the FDA will not regulate low risk products intended only for general wellness. Specifically, the agency divided general wellness products into two categories:
1. Products that do not make any reference to diseases or medical conditions
2. Products that may help of reduce the risk of and products that may help living well with certain chronic diseases or conditions
The agency hopes that its policy will foster further development of low-risk products intended to promote a healthy lifestyle.
As for medical device accessories, the FDA will regulate based on the accessory’s individual risks and not based on the risks of its parent device. For example, if a parent device is regulated as a Class III device, but the accessory is low risk, the accessory could be regulated as a Class I.
Public comments and suggestions regarding the draft documents are due within 90 days of publication.
FDA issues and regulations are major evolving issue for telehealth and mHealth providers. Any additional guidance from the FDA is a welcomed development, to the extent that it in any way clarifies the FDA’s thinking on regulatory evolving health care delivery technologies.
For more information, or for questions related to medical devices, please contact Adrienne Dresevic, Esq. at firstname.lastname@example.org, or Clinton Mikel, Esq. at email@example.com, or call (248)996-8510.