{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled \"Predetermined Change Control Plans for Medical Devices.\" A predetermined change control plan (PCCP) is the documentation describing what modifications will be made to a device and how the modifications will be assessed. This draft guidance provides FDA's current thinking on a policy for PCCPs and recommendations on the information to include in a PCCP in a marketing submission for a device. This draft guidance is not final nor is it for implementation at this time.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN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/2024/08/22/2024-18828.html","cfr_references":[],"citation":"89 FR 67945","comment_url":null,"comments_close_on":"2024-11-20","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by November 20, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-2024-D-2338"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":6,"comment_start_date":"2024-08-22","updated_at":"2024-11-22T00:01:49.484-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2024-D-2338-0001","allow_late_comments":false,"id":"FDA-2024-D-2338-0001","comment_end_date":"2024-11-21","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2024-D-2338","title":"Predetermined Change Control Plans for Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability"}],"document_number":"2024-18828","effective_on":null,"end_page":67947,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/08/22/2024-18828.xml","html_url":"https://www.federalregister.gov/documents/2024/08/22/2024-18828/predetermined-change-control-plans-for-medical-devices-draft-guidance-for-industry-and-food-and-drug","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-18828?publication_date=2024-08-22","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-08-22/2024-18828/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1139,"last_updated":"2026-05-29 12:15:10 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-08-22/pdf/2024-18828.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-18828.pdf?1724244338","publication_date":"2024-08-22","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/08/22/2024-18828.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":6,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2024-D-2338","supporting_documents_count":0,"docket_id":"FDA-2024-D-2338","document_id":"FDA-2024-D-2338-0001","regulation_id_number":null,"title":"Predetermined Change Control Plans for Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","checked_regulationsdotgov_at":"2024-11-23T02:00:06Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":67945,"subtype":null,"title":"Predetermined Change Control Plans for Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Predetermined Change Control Plans for Medical Devices","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":89}