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  • Title: Medical Devices; Exemptions From Premarket Notification: Class II Devices. Final order.
    Author: Food and Drug Administration, HHS.
    Journal: Fed Regist; 2018 Jun 05; 83(108):25910-5. PubMed ID: 30019871.
    Abstract:
    The Food and Drug Administration (FDA or the Agency) is publishing an order to exempt a list of class II devices from premarket notification (510(k)) requirements, subject to certain limitations. This exemption from 510(k), subject to certain limitations, is immediately in effect for the listed class II devices. This exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. FDA is also amending the codified language for the listed class II devices to reflect this final determination. FDA is publishing this order in accordance with the section of the Federal Food, Drug, and Cosmetic Act (FD&C Act) permitting the exemption of a device from the requirement to submit a 510(k).
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