The U.S. Food and Drug Administration (FDA) has released several important guidance documents over the past two months. On January 20, 2015, the FDA issued a draft document for general wellness products, such as fitness bands and smartphone applications. The guidance describes categories of general wellness products and states that the FDA will not examine low risk wellness products to determine whether they qualify as medical devices.
Also on January 20, 2015, the FDA published a draft framework for approving and classifying medical device accessories. In this draft, the FDA defines a medical device “accessory” and discusses how the risk of an accessory will be assessed based on its intended use. It should be noted that the FDA will not necessarily automatically adopt the same risk classification as the accessory’s parent device. The FDA also recommends that medical companies use the de novo pathway for device accessories in order to allow companies to market their accessories more quickly.
The FDA released draft documents in February 2015 concerning drug compounding, repackaging and labeling. One draft guidance document outlines whether a facility should register with the FDA as an outsourcing facility and provides information about the regulatory issues involved. A second draft guidance explains adverse event reporting for such facilities. A third draft guidance addresses repackaging drugs, while a fourth looks at mixing, diluting or repackaging biological products.
A fifth draft guidance addresses consumer-directed print advertisements and promotional labeling for drugs. For labeling, the draft guidance encourages companies to only provide an abbreviated statement of product risk instead of the full prescribing information. This is in contrast to the current regulatory requirement for consumer-directed drug promotional labeling, which is to provide the full prescribing information.