{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled \"Unique Device Identification: Direct Marking of Devices.\" Direct marking is an important feature of FDA's unique device identification system. This document is intended to assist industry and FDA staff to understand FDA's requirements for direct marking of devices with a unique device identifier (UDI). In addition, FDA is seeking information on what processes should be considered to meet the definition of \"reprocessing\" for purposes of UDI direct marking requirements.","action":"Notice.","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/2015/06/26/2015-15719.html","cfr_references":[],"citation":"80 FR 36821","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 24, 2015.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-D-2245"],"dockets":[],"document_number":"2015-15719","effective_on":null,"end_page":36822,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/06/26/2015-15719.xml","html_url":"https://www.federalregister.gov/documents/2015/06/26/2015-15719/unique-device-identification-direct-marking-of-devices-draft-guidance-for-industry-and-food-and-drug","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-15719?publication_date=2015-06-26","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-06-26/2015-15719/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":7088,"last_updated":"2026-04-04 20:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-06-26/pdf/2015-15719.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-15719.pdf?1435236389","publication_date":"2015-06-26","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/06/26/2015-15719.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2015-D-2245","supporting_documents_count":0,"docket_id":"FDA-2015-D-2245","regulation_id_number":null,"title":"Unique Device Identification: Direct Marking of Devices","checked_regulationsdotgov_at":"2015-09-25T05:01:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":36821,"subtype":null,"title":"Unique Device Identification: Direct Marking of Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability and Request for Comments","toc_doc":"Unique Device Identification  Direct Marking of Devices","toc_subject":"Guidance for Industry and Staff:","topics":[],"type":"Notice","volume":80}