{"abstract":"The Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) is announcing the availability of a CDRH eSubmissions Pilot Program (eSubmissions Pilot), which will be a new pathway that will guide the user through constructing and submitting their 510(k) submissions electronically without the requirement for submitting a hard copy or a compact disc. Participation in the eSubmissions Pilot is open to applicants whose device submissions would be reviewed in either of two branches in CDRH's Office of Device Evaluation (ODE), the Cardiac Diagnostic Devices Branch and the Peripheral Interventional Devices Branch, and is limited to unbundled, traditional 510(k) submissions for classified devices only. The eSubmissions Pilot will use the existing eSubmitter software for data acquisition and the existing Electronic Submission Gateway (ESG) for submitting (the eSubmissions Pilot is not intended to evaluate the existing eSubmitter software or the existing ESG). The eSubmissions Pilot is intended to provide industry and CDRH staff the opportunity to evaluate the 510(k) eSubmission with regards to the content (wording of questions, help text and guides), layout, and flow of the questions.","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/2014/05/01/2014-09912.html","cfr_references":[],"citation":"79 FR 24732","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"FDA will begin accepting requests to participate in the eSubmissions Pilot immediately. See the \"Procedures\" section for instructions on how to submit a request.","disposition_notes":null,"docket_ids":["Docket No. FDA-2014-N-0366"],"dockets":[],"document_number":"2014-09912","effective_on":null,"end_page":24734,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/05/01/2014-09912.xml","html_url":"https://www.federalregister.gov/documents/2014/05/01/2014-09912/pilot-program-for-center-for-devices-and-radiological-health-electronic-submission-of-premarket","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-09912?publication_date=2014-05-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-05-01/2014-09912/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":712,"last_updated":"2026-07-27 22:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-05-01/pdf/2014-09912.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-09912.pdf?1398862194","publication_date":"2014-05-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/05/01/2014-09912.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-2014-N-0366","supporting_documents_count":0,"docket_id":"FDA-2014-N-0366","regulation_id_number":null,"title":"Pilot Program for Center for Devices and Radiological Health Electronic Submission of Premarket Notification Submissions","checked_regulationsdotgov_at":"2014-05-21T08:07:18Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":24732,"subtype":null,"title":"Pilot Program for Center for Devices and Radiological Health Electronic Submission of Premarket Notification Submissions","toc_doc":"Center for Devices and Radiological Health Electronic Submission of Premarket Notification Submissions; Pilot Program","toc_subject":"Guidance for Industry and Staff:","topics":[],"type":"Notice","volume":79}