{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled \"Regulatory Considerations for Microneedling Products.\" This guidance is being issued to assist industry in understanding when a microneedling product is a device as defined in the Federal Food, Drug, and Cosmetic Act (FD&C Act). This document also provides information on the regulatory pathway to market for microneedling devices for aesthetic use.","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/2020/11/10/2020-24943.html","cfr_references":[],"citation":"85 FR 71656","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on November 10, 2020.","disposition_notes":null,"docket_ids":["Docket No. FDA-2017-D-4792"],"dockets":[],"document_number":"2020-24943","effective_on":null,"end_page":71658,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/11/10/2020-24943.xml","html_url":"https://www.federalregister.gov/documents/2020/11/10/2020-24943/regulatory-considerations-for-microneedling-products-guidance-for-industry-and-food-and-drug","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-24943?publication_date=2020-11-10","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-11-10/2020-24943/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1636,"last_updated":"2026-07-27 08:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-11-10/pdf/2020-24943.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-24943.pdf?1604929533","publication_date":"2020-11-10","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/11/10/2020-24943.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2017-D-4792","supporting_documents_count":0,"docket_id":"FDA-2017-D-4792","document_id":"FDA-2017-D-4792-0010","regulation_id_number":null,"title":"Regulatory Considerations for Microneedling Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","checked_regulationsdotgov_at":"2020-11-12T04:30:08Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":71656,"subtype":null,"title":"Regulatory Considerations for Microneedling Products; Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Regulatory Considerations for Microneedling Products","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":85}