federal_register: 2016-29989

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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
2016-29989 Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”); 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 guidance entitled "Public Notification of Emerging Postmarket Medical Device Signals (`Emerging Signals')." FDA is issuing this guidance to describe the Center for Devices and Radiological Health's (CDRH) policy for notifying the public about medical device "emerging signals." This guidance describes the factors CDRH intends to consider in deciding whether to notify the public about an emerging signal and the processes and timelines it intends to follow in issuing and updating the notification. Timely notification about those emerging signals based on the factors described in this guidance document is intended to provide health care providers, patients, and consumers with access to the most current information concerning the performance and potential benefits and risks of marketed medical devices so that they can make informed patient management decisions about their treatment and diagnostic options. 2016-12-14 2016 12 https://www.federalregister.gov/documents/2016/12/14/2016-29989/public-notification-of-emerging-postmarket-medical-device-signals-emerging-signals-guidance-for https://www.govinfo.gov/content/pkg/FR-2016-12-14/pdf/2016-29989.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 guidance entitled "Public Notification of Emerging Postmarket Medical Device Signals (`Emerging Signals')." FDA is issuing this guidance to describe the Center for...  

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