federal_register: 2020-25306

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2020-25306 Electromagnetic Compatibility of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Electromagnetic Compatibility (EMC) of Medical Devices." FDA has developed this guidance document to describe relevant information that should be provided in a premarket submission (i.e., premarket approval application (PMA), humanitarian device exemption (HDE), premarket notification (510(k)) submission, investigational device exemption (IDE), and De Novo request) to support a claim of electromagnetic compatibility for electrically powered medical devices and medical devices with electrical or electronic functions. This draft guidance is not intended to change current policy, but to provide specific technical information to address the recommendations originally described in the guidance entitled "Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices" published July 11, 2016 (2016 EMC guidance). This draft guidance is not final nor is it in effect at this time. 2020-11-17 2020 11 https://www.federalregister.gov/documents/2020/11/17/2020-25306/electromagnetic-compatibility-of-medical-devices-draft-guidance-for-industry-and-food-and-drug https://www.govinfo.gov/content/pkg/FR-2020-11-17/pdf/2020-25306.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Electromagnetic Compatibility (EMC) of Medical Devices." FDA has developed this guidance document to describe relevant information that...  

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