federal_register: 2020-06278

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2020-06278 Medical Devices; Technical Amendment Rule The Food and Drug Administration (FDA or Agency) is amending certain medical device regulations to accurately reflect the devices exempted from premarket notification (510(k)) as indicated in the lists published on April 13, 2017, and July 11, 2017. FDA published a final amendment, final order in the Federal Register of December 30, 2019 ("Final Order") codifying the two Federal Register notices. The present revisions are necessary to correct editorial errors to ensure that the codified is consistent with the exemptions in the Federal Register notices. The rule does not impose any new regulatory requirements on affected parties. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations. 2020-04-02 2020 4 https://www.federalregister.gov/documents/2020/04/02/2020-06278/medical-devices-technical-amendment https://www.govinfo.gov/content/pkg/FR-2020-04-02/pdf/2020-06278.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is amending certain medical device regulations to accurately reflect the devices exempted from premarket notification (510(k)) as indicated in the lists published on April 13, 2017, and July 11, 2017....

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