federal_register: 2019-27394

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2019-27394 Medical Devices; Exemptions From Premarket Notification for Class I and Class II Devices Rule The Food and Drug Administration (FDA, Agency, or we) identified a list of class I devices and class II devices that are now exempt from premarket notification requirements, subject to certain limitations. FDA published the lists of final determinations in accordance with procedures established by the 21st Century Cures Act (Cures Act). Although each classification regulation for each such type of device shall be deemed amended to incorporate such exemption, we are publishing this final order to amend the codified language for each listed class I and class II device's classification regulation to reflect the final determinations. FDA's action decreases regulatory burden on the medical device industry and eliminates private costs and expenditures required to comply with certain Federal regulations. 2019-12-30 2019 12 https://www.federalregister.gov/documents/2019/12/30/2019-27394/medical-devices-exemptions-from-premarket-notification-for-class-i-and-class-ii-devices https://www.govinfo.gov/content/pkg/FR-2019-12-30/pdf/2019-27394.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA, Agency, or we) identified a list of class I devices and class II devices that are now exempt from premarket notification requirements, subject to certain limitations. FDA published the lists of final...

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