{"abstract":"The Food and Drug Administration (FDA) is soliciting nominations for participation in a pilot program for the submission of medical device reports for malfunctions of class I devices and certain class II devices in summary format on a quarterly basis. Under the Medical Device Reporting on Malfunctions pilot program, FDA intends to work with manufacturers to identify candidates for the pilot program and intends to continue to accept nominations until candidates for the pilot program have been selected.","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/2015/08/18/2015-20309.html","cfr_references":[],"citation":"80 FR 50010","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"FDA will begin accepting nominations for participation in the voluntary pilot program on September 1, 2015, and intends to continue to accept nominations until candidates for the pilot program have been selected. See section II for instructions on how to participate in the voluntary pilot program.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-N-2918"],"dockets":[],"document_number":"2015-20309","effective_on":null,"end_page":50013,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/08/18/2015-20309.xml","html_url":"https://www.federalregister.gov/documents/2015/08/18/2015-20309/pilot-program-for-medical-device-reporting-on-malfunctions","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-20309?publication_date=2015-08-18","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-08-18/2015-20309/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":1975,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-08-18/pdf/2015-20309.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-20309.pdf?1439815564","publication_date":"2015-08-18","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/08/18/2015-20309.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-2015-N-2918","supporting_documents_count":0,"docket_id":"FDA-2015-N-2918","regulation_id_number":null,"title":"Pilot Program for Medical Device Reporting on Malfunctions","checked_regulationsdotgov_at":"2015-09-07T06:00:16Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":50010,"subtype":null,"title":"Pilot Program for Medical Device Reporting on Malfunctions","toc_doc":"Pilot Program for Medical Device Reporting on Malfunctions","toc_subject":"Requests for Nominations:","topics":[],"type":"Notice","volume":80}