federal_register: 2016-25026

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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
2016-25026 Electronic Submission of Labeling for Certain Home-Use Medical Devices Proposed Rule The Food and Drug Administration (FDA) is proposing to implement provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to require electronic submission of the device label and package insert of certain home-use devices when these devices are listed with FDA. FDA plans to make this device labeling available to the public through the Internet and would also provide search tools to facilitate locating information concerning a particular home-use device or a particular type of home-use device. 2016-10-17 2016 10 https://www.federalregister.gov/documents/2016/10/17/2016-25026/electronic-submission-of-labeling-for-certain-home-use-medical-devices https://www.govinfo.gov/content/pkg/FR-2016-10-17/pdf/2016-25026.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is proposing to implement provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to require electronic submission of the device label and package insert of certain home-use devices when these...  

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