federal_register: 2019-27047

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2019-27047 Medical Device Submissions: Amending Premarket Regulations That Require Multiple Copies and Specify Paper Copies To Be Required in Electronic Format Rule The Food and Drug Administration (FDA, Agency, or we) is issuing a final rule amending requirements for medical device premarket submissions to remove paper and multiple copies and replace them with requirements for a single submission in electronic format. This action would reduce the number of copies in electronic format required, thus improving and making more efficient the FDA's premarket submission program for medical devices. 2019-12-16 2019 12 https://www.federalregister.gov/documents/2019/12/16/2019-27047/medical-device-submissions-amending-premarket-regulations-that-require-multiple-copies-and-specify https://www.govinfo.gov/content/pkg/FR-2019-12-16/pdf/2019-27047.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA, Agency, or we) is issuing a final rule amending requirements for medical device premarket submissions to remove paper and multiple copies and replace them with requirements for a single submission in electronic... 0910-AH48

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