21 U.S.C. § 360f — Banned devices

(a) General rule Based on all available data and information, the Secretary can start a proceeding to ban a medical device — or ban one or more of its intended uses — if the device presents "substantial deception" or an "unreasonable and substantial risk of illness or injury" for those uses. If the Secretary decided that the deception or risk could be fixed through labeling or a labeling change, the Secretary must first have given the manufacturer written notice explaining the deception or risk, the labeling change needed to fix it, and a deadline for making that change. The Secretary can only move forward with the ban if the manufacturer failed to make that labeling change within the given period. Once a device, or a specific use of it, is banned, it is not a "legally marketed device" under section 396 when intended for that use. (b) Special effective date The Secretary may make a proposed ban effective immediately upon its publication in the Federal Register — and keep it in effect until a final decision is made — if two things are true: the Secretary determines, based on all available data and information, that the device's deception or risk of illness or injury presents an unreasonable, direct, and substantial danger to health; and, before publishing the proposed rule, the Secretary notified the manufacturer that this immediate ban was coming. If the Secretary does make a ban effective this way, the Secretary must then, as quickly as possible, give interested persons prompt notice of the action, provide a reasonable opportunity for an informal hearing on the proposed rule, and afterward either affirm, modify, or revoke it.