{"abstract":"The Food and Drug Administration's (FDA, Agency, or we) Center for Devices and Radiological Health (CDRH or Center) is announcing its 510(k) Sterility Change Master File Pilot Program (\"510(k) Sterility Pilot Program\"). The 510(k) Sterility Pilot Program is voluntary and intends to give interested companies that terminally sterilize single- use devices (\"sterilization providers\") using certain sterilization methods a pathway to submit a Master File for FDA's review. FDA will accept a Master File into the 510(k) Sterility Pilot Program when it determines, among other things, that there is not a likelihood that switching from a fixed chamber ethylene oxide (EtO) sterilization method to the sterilization method described in the Master File could significantly affect the safety or effectiveness of a 510(k)-cleared device that meets the product definition in the Master File and that satisfies other conditions outlined in this document. If a Master File is accepted into the 510(k) Sterility Pilot Program, manufacturers of 510(k)-cleared devices (\"510(k) holders\") may choose to reference the Master File in internal documentation in support of a justification for not submitting a new premarket notification (510(k)) under certain conditions as outlined in this document. This voluntary pilot program seeks to encourage industry to consider new, innovative ways to sterilize devices that reduce the potential impact of EtO on the environment and on public health, while ensuring consistent patient access to safe devices and providing a framework for future regulatory approaches that would help address potential device shortages related to EtO sterilization.","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/2022/05/20/2022-10925.html","cfr_references":[],"citation":"87 FR 30957","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"FDA is seeking participation in the voluntary 510(k) Sterility Pilot Program beginning May 20, 2022. See the \"Participation\" section for selection criteria for sterilization providers to participate in the 510(k) Sterility Pilot Program and the \"Procedures\" section for instructions on how to submit a Master File for consideration for inclusion into the 510(k) Sterility Pilot Program. Up to nine eligible sterilization providers may be selected for participation in the 510(k) Sterility Pilot Program.","disposition_notes":null,"docket_ids":["Docket No. FDA-2022-N-0517"],"dockets":[],"document_number":"2022-10925","effective_on":null,"end_page":30961,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/05/20/2022-10925.xml","html_url":"https://www.federalregister.gov/documents/2022/05/20/2022-10925/medical-devices-510k-sterility-change-master-file-pilot-program","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-10925?publication_date=2022-05-20","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-05-20/2022-10925/mods.xml","not_received_for_publication":null,"page_length":5,"page_views":{"count":3097,"last_updated":"2026-05-27 12:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-05-20/pdf/2022-10925.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-10925.pdf?1652964338","publication_date":"2022-05-20","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/05/20/2022-10925.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-2022-N-0517","supporting_documents_count":0,"docket_id":"FDA-2022-N-0517","document_id":"FDA-2022-N-0517-0001","regulation_id_number":null,"title":"Medical Devices; 510(k) Sterility Change Master File Pilot Program","checked_regulationsdotgov_at":"2022-05-21T03:30:06Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":30957,"subtype":null,"title":"Medical Devices; 510(k) Sterility Change Master File Pilot Program","toc_doc":"510(k) Sterility Change Master File Pilot Program","toc_subject":"Medical Devices:\n","topics":[],"type":"Notice","volume":87}