{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing a list of class II devices that the Agency has determined based on established factors to no longer require premarket notification to provide reasonable assurance of safety and effectiveness, subject to certain limitations. FDA is publishing this notice of that determination in accordance with procedures established by the 21st Century Cures Act. This notice represents FDA's final determination with respect to the list of class II devices proposed in a March 14, 2017, Federal Register document. The exemptions in this notice will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations.","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/2017/07/11/2017-14453.html","cfr_references":[],"citation":"82 FR 31976","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2017-N-1129"],"dockets":[],"document_number":"2017-14453","effective_on":null,"end_page":32002,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2017/07/11/2017-14453.xml","html_url":"https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2017-14453?publication_date=2017-07-11","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2017-07-11/2017-14453/mods.xml","not_received_for_publication":null,"page_length":27,"page_views":{"count":23839,"last_updated":"2026-04-24 08:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2017-07-11/pdf/2017-14453.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2017-14453.pdf?1499690754","publication_date":"2017-07-11","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2017/07/11/2017-14453.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Attachment 9 Becker, E. High Resolution NMR (Third Edition)\nTheory and Chemical Applications Table of Contents re: Comment from Bruker","document_id":"FDA-2017-N-1129-0051"},{"title":"Attachment 8 Becker, E. A Brief History of Nuclear Magnetic Resonance Anal Chemistry, 65, 6, (1993) re: Comment from Bruker","document_id":"FDA-2017-N-1129-0050"},{"title":"Attachment 7 History of Bruker re: Comment from Bruker","document_id":"FDA-2017-N-1129-0049"},{"title":"Attachment 2 Beger et al Metabolomics enables precision medicine: \"A White Paper, Community Perspective\" Metabolomics (20 16) I 2:149 re: Comment from Bruker","document_id":"FDA-2017-N-1129-0048"},{"title":"Attachment 1 Improvement of Biological Product Quality by Application of New Technologies to Characterize of Vaccines and Blood Products: NMR Spectroscopy and Light Scattering re: Comment from Bruker","document_id":"FDA-2017-N-1129-0047"},{"title":"Reference 1 - Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff re: Medical Devices: Exemptions From Premarket Notification; Class II Devices; Request for Comments","document_id":"FDA-2017-N-1129-0002"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2017-N-1129","supporting_documents_count":6,"docket_id":"FDA-2017-N-1129","regulation_id_number":null,"title":"Medical Devices; Exemptions From Premarket Notification: Class II Devices","checked_regulationsdotgov_at":"2017-07-31T06:00:21Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":31976,"subtype":null,"title":"Medical Devices; Exemptions From Premarket Notification: Class II Devices","toc_doc":"Exemptions from Premarket Notification; Class II Devices","toc_subject":"Medical Devices:","topics":[],"type":"Notice","volume":82}