{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry and FDA staff entitled \"Classification of Products as Drugs and Devices & Additional Product Classification Issues.\" This guidance provides the Agency's current thinking on approaches for classifying products as drugs and devices, and on certain additional product classification issues.","action":"Notice of availability.","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/2017/09/26/2017-20522.html","cfr_references":[],"citation":"82 FR 44802","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on September 26, 2017.","disposition_notes":null,"docket_ids":["Docket No. FDA-2011-D-0429"],"dockets":[],"document_number":"2017-20522","effective_on":null,"end_page":44803,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2017/09/26/2017-20522.xml","html_url":"https://www.federalregister.gov/documents/2017/09/26/2017-20522/classification-of-products-as-drugs-and-devices-and-additional-product-classification-issues","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2017-20522?publication_date=2017-09-26","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2017-09-26/2017-20522/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1884,"last_updated":"2026-10-23 16:15:07 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2017-09-26/pdf/2017-20522.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2017-20522.pdf?1506343553","publication_date":"2017-09-26","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2017/09/26/2017-20522.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-2011-D-0429","supporting_documents_count":0,"docket_id":"FDA-2011-D-0429","regulation_id_number":null,"title":"Classification of Products as Drugs and Devices & Additional Product Classification Issues","checked_regulationsdotgov_at":"2017-10-16T06:00:25Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":44802,"subtype":null,"title":"Classification of Products as Drugs and Devices and Additional Product Classification Issues; Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Classification of Products as Drugs and Devices and Additional Product Classification Issues","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":82}