{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled \"Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin.\" FDA has developed this draft guidance to propose select updates to FDA's current thinking regarding the type of biocompatibility information that should be provided in a premarket submission for certain devices made from common polymers and fabrics that are in contact with intact skin. This draft guidance is not final nor is it in effect at this time.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN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/2020/10/15/2020-22876.html","cfr_references":[],"citation":"85 FR 65410","comment_url":null,"comments_close_on":"2020-12-14","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by December 14, 2020 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-D-0350"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":7,"comment_start_date":"2020-10-15","updated_at":"2023-02-28T22:42:22.733-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2013-D-0350-0042","allow_late_comments":null,"id":"FDA-2013-D-0350-0042","comment_end_date":"2020-12-15","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2013-D-0350","title":"Use of International Standard ISO-10993, “Biological Evaluation of Medical Devices Part1: Evaluation and Testing”; Draft Guidance for Industry and Food and Drug Administration Staff; Availability"}],"document_number":"2020-22876","effective_on":null,"end_page":65412,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/10/15/2020-22876.xml","html_url":"https://www.federalregister.gov/documents/2020/10/15/2020-22876/select-updates-for-biocompatibility-of-certain-devices-in-contact-with-intact-skin-draft-guidance","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-22876?publication_date=2020-10-15","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-10-15/2020-22876/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1511,"last_updated":"2026-08-25 06:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-10-15/pdf/2020-22876.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-22876.pdf?1602679550","publication_date":"2020-10-15","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/10/15/2020-22876.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":7,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2013-D-0350","supporting_documents_count":0,"docket_id":"FDA-2013-D-0350","document_id":"FDA-2013-D-0350-0042","regulation_id_number":null,"title":"Use of International Standard ISO-10993, “Biological Evaluation of Medical Devices Part1: Evaluation and Testing”; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","checked_regulationsdotgov_at":"2023-03-01T03:42:21Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":65410,"subtype":null,"title":"Select Updates for Biocompatibility of Certain Devices in Contact With Intact Skin; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Select Updates for Biocompatibility of Certain Devices in Contact With Intact Skin","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":85}