federal_register: 2019-07290

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2019-07290 Medical Devices; Classification of Accessories Distinct From Other Devices; Finalized List of Accessories Suitable for Class I Rule The Food and Drug Administration (FDA, we, or Agency) is classifying suitable accessories into class I as required by the FDA Reauthorization Act of 2017 (FDARA). The Agency has determined that general controls alone are sufficient to provide reasonable assurance of safety and effectiveness for these accessories. We made this determination based on the risks of the accessories when used as intended with other devices such as the parent or system. 2019-04-12 2019 4 https://www.federalregister.gov/documents/2019/04/12/2019-07290/medical-devices-classification-of-accessories-distinct-from-other-devices-finalized-list-of https://www.govinfo.gov/content/pkg/FR-2019-04-12/pdf/2019-07290.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA, we, or Agency) is classifying suitable accessories into class I as required by the FDA Reauthorization Act of 2017 (FDARA). The Agency has determined that general controls alone are sufficient to provide...

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