federal_register: 03-2375

All Federal Register documents (rules, proposed rules, notices, presidential documents) from 1994 to present. Nearly 1M documents with full-text search.

This data as json

document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
03-2375 Medical Devices; Final Guidance on Quality System Information for Certain Premarket Application Reviews; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a final guidance entitled "Quality System Information for Certain Premarket Application Reviews." This guidance has been prepared by the Center for Devices and Radiological Health (CDRH), in coordination with the Center for Biologics Evaluation and Research (CBER), to assist medical device manufacturers in preparing and maintaining the quality system (QS) information required in certain premarket submissions. 2003-02-03 2003 2 https://www.federalregister.gov/documents/2003/02/03/03-2375/medical-devices-final-guidance-on-quality-system-information-for-certain-premarket-application https://www.govinfo.gov/content/pkg/FR-2003-02-03/pdf/03-2375.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a final guidance entitled "Quality System Information for Certain Premarket Application Reviews." This guidance has been prepared by the Center for Devices and Radiological Health...

Links from other tables