federal_register: E8-13349

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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
E8-13349 Medical Devices; Medical Device Reporting; Baseline Reports; Companion to Direct Final Rule Proposed Rule The Food and Drug Administration (FDA) is proposing to amend its medical device reporting regulations to remove a requirement for baseline reports that the agency deems no longer necessary. Currently, manufacturers provide baseline reports to FDA that include the FDA product code and the premarket approval or premarket notification number. Because most of the information in these baseline reports is also submitted to FDA in individual adverse event reports, FDA is proposing to remove the requirement for baseline reports. The removal of this requirement would eliminate unnecessary duplication and reduce the manufacturer's reporting burden. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register. 2008-06-13 2008 6 https://www.federalregister.gov/documents/2008/06/13/E8-13349/medical-devices-medical-device-reporting-baseline-reports-companion-to-direct-final-rule https://www.govinfo.gov/content/pkg/FR-2008-06-13/pdf/E8-13349.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is proposing to amend its medical device reporting regulations to remove a requirement for baseline reports that the agency deems no longer necessary. Currently, manufacturers provide baseline reports to FDA that...  

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