Decisions by the U.S. Food and Drug Administration (FDA) have a tremendous impact on Israeli-based medical and pharmaceutical companies that manufacture products that are marketed and sold in the United States and around the world. On Jan. 20, 2015, the FDA issued two anticipated draft guidance documents proposing reduced FDA oversight of two types of products: low-risk general wellness products and medical device accessories. The guidances are intended to provide clarity to industry and FDA staff regarding the Center for Devices and Radiological Health’s compliance policy for low-risk products that promote a healthy lifestyle, rather than treat or diagnose, and for accessories to regulated medical devices. The FDA is soliciting comments on this guidance and it is unclear when this will be considered final or what the enforcement of these devices will entail prior to completion of the final guidance. In this Client Alert, authors Evan C. Holden and Victoria Davis Locard, both attorneys in Greenberg Traurig‘s Atlanta office, explain the drafts and the criteria necessary to classify a product or device as low risk.

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