{"abstract":"The Food and Drug Administration (FDA) is implementing the postmarket surveillance (PS) provisions of the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). The purpose of this rule is to provide for the collection of useful data about devices that can reveal unforeseen adverse events or other information necessary to protect the public health.","action":"Final rule.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2002/06/06/02-14100.html","cfr_references":[{"chapter":null,"citation_url":null,"part":822,"title":21}],"citation":"67 FR 38878","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective July 8, 2002.","disposition_notes":null,"docket_ids":["Docket No. 00N-1367"],"dockets":[],"document_number":"02-14100","effective_on":"2002-07-08","end_page":38892,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2002/06/06/02-14100.xml","html_url":"https://www.federalregister.gov/documents/2002/06/06/02-14100/postmarket-surveillance","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/02-14100?publication_date=2002-06-06","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2002-06-06/02-14100/mods.xml","not_received_for_publication":null,"page_length":15,"page_views":{"count":284,"last_updated":"2026-07-27 10:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2002-06-06/pdf/02-14100.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2002-06-06","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2002/06/06/02-14100.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":38878,"subtype":null,"title":"Postmarket Surveillance","toc_doc":"Postmarket surveillance","toc_subject":"Medical devices:","topics":["Medical devices","Reporting and recordkeeping requirements"],"type":"Rule","volume":67}