{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Guidance Document for Industry and CDRH Staff for the Preparation of Investigational Device Exemptions and Premarket Approval Applications for Bone Growth Stimulator Devices.'' This guidance is not final or in effect at this time. The purpose of this document is to suggest to the device manufacturer or investigation sponsor important information which should be presented in investigational device exemption (IDE) and premarket approval (PMA) applications in order to provide reasonable assurance of the safety and effectiveness of these devices for their intended uses.","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/1998/04/28/98-11158.html","cfr_references":[],"citation":"63 FR 23292","comment_url":null,"comments_close_on":"1998-07-27","correction_of":null,"corrections":[],"dates":"Written comments concerning this guidance must be submitted by July 27, 1998.","disposition_notes":null,"docket_ids":["Docket No. 98D-0238"],"dockets":[],"document_number":"98-11158","effective_on":null,"end_page":23293,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":null,"html_url":"https://www.federalregister.gov/documents/1998/04/28/98-11158/guidance-document-for-industry-and-cdrh-staff-for-the-preparation-of-investigational-device","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/98-11158?publication_date=1998-04-28","mods_url":"https://www.govinfo.gov/metadata/granule/FR-1998-04-28/98-11158/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":705,"last_updated":"2026-09-23 02:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-1998-04-28/pdf/98-11158.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"1998-04-28","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/1998/04/28/98-11158.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-09-21T03:58:29Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":23292,"subtype":null,"title":"Guidance Document for Industry and CDRH Staff for the Preparation of Investigational Device Exemptions and Premarket Approval Applications for Bone Growth Stimulator Devices; Draft; Availability","toc_doc":null,"toc_subject":null,"topics":[],"type":"Notice","volume":63}