FDA proposed guidance looks at wellness products, medical device accessories

Two draft documents released by the FDA illuminate its thinking on the regulation of general wellness products and medical device accessories.

The proposed guidance, published to comply with the actions stipulated in the FDASIA Health IT Report, reveals that the FDA intends only to regulate a general wellness product when its use is marketed for a specific disease or condition. Devices that are more intrusive and involve more than tracking of exercise, diets and heart rates would require more regulatory oversight.

Devices aren’t considered general wellness if they purport to treat or diagnose obesity, anorexia, anxiety, muscle atrophy or erectile dysfunction. Also, computer games that claim to diagnose or treat autism do not fall under the definition of a general wellness product.

The FDA also released draft guidance on medical device accessories, for which the agency wrote that the key determinant of its risks is in its relationship to its parent device. However, the risk an accessory poses may be different than that of its parent device, thus requiring a different level of regulatory oversight.

The guidance recommended the use of a new classification pathway for some device accessories so manufacturers can more quickly get their products to market.

Read the proposed general wellness product guidance or medical device accessory guidance. 

Stakeholders have 90 days to provide feedback on the proposed documents.