{"abstract":"The Food and Drug Administration's (FDA or Agency) Center for Devices and Radiological Health (CDRH or Center) is announcing its voluntary Electronic Submission Template and Resource (eSTAR) Pilot Program. The eSTAR Pilot Program is voluntary and intends to improve consistency and efficiency in both industry's preparation and FDA's review of premarket notification (510(k)) submissions. During the voluntary eSTAR Pilot Program, pilot participants will have the opportunity to provide input to FDA on eSTAR.","action":"Notice; request for comments.","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/2020/02/27/2020-03945.html","cfr_references":[],"citation":"85 FR 11371","comment_url":"https://www.regulations.gov/commenton/FDA-2020-N-0625-0001","comments_close_on":"2020-02-27","correction_of":null,"corrections":[],"dates":"FDA is seeking participation in the voluntary eSTAR Pilot Program beginning February 27, 2020. See section I.A. for instructions on how to submit a request to participate. The voluntary eSTAR Pilot Program will select up to nine participants who best match the selection criteria. This pilot program will begin February 27, 2020.","disposition_notes":null,"docket_ids":["Docket No. FDA-2020-N-0625"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2020-02-27","updated_at":"2024-11-06T19:04:38.795-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2020-N-0625-0001","allow_late_comments":true,"id":"FDA-2020-N-0625-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2020-N-0625","title":"Improving 510(k) Submission Preparation and Review: Voluntary Electronic Submission Template and Resource Pilot Program"}],"document_number":"2020-03945","effective_on":null,"end_page":11373,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/02/27/2020-03945.xml","html_url":"https://www.federalregister.gov/documents/2020/02/27/2020-03945/improving-510k-submission-preparation-and-review-voluntary-electronic-submission-template-and","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-03945?publication_date=2020-02-27","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-02-27/2020-03945/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":3309,"last_updated":"2026-08-24 14:15:12 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-02-27/pdf/2020-03945.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-03945.pdf?1582724731","publication_date":"2020-02-27","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/02/27/2020-03945.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-2020-N-0625","supporting_documents_count":0,"docket_id":"FDA-2020-N-0625","document_id":"FDA-2020-N-0625-0001","regulation_id_number":null,"title":"Improving 510(k) Submission Preparation and Review: Voluntary Electronic Submission Template and Resource Pilot Program","checked_regulationsdotgov_at":"2024-11-07T23:00:19Z"},"regulations_dot_gov_url":"https://www.regulations.gov/commenton/FDA-2020-N-0625-0001","significant":null,"signing_date":null,"start_page":11371,"subtype":null,"title":"Improving 510(k) Submission Preparation and Review: Voluntary Electronic Submission Template and Resource Pilot Program; Request for Comments","toc_doc":"Improving 510(k) Submission Preparation and Review: Voluntary Electronic Submission Template and Resource Pilot Program","toc_subject":"Request for Comments:","topics":[],"type":"Notice","volume":85}