{"abstract":"The Food and Drug Administration (FDA or Agency) has determined that it is necessary for manufacturers of certain reusable medical devices to include in their premarket notifications (510(k)s) instructions for use which have been validated and validation data regarding cleaning, disinfection, and sterilization, for which a substantial equivalence determination may be based. This notice includes a list of these reusable devices that will require validated instructions for use and validation data in their premarket notification. FDA is publishing this list in accordance with the requirements established by the 21st Century Cures Act. This action ensures that the premarket requirements for these device types are clear and predictable which facilitates more efficient review of these 510(k)s.","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/2017/06/09/2017-12007.html","cfr_references":[],"citation":"82 FR 26807","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"These actions are effective on August 8, 2017.","disposition_notes":null,"docket_ids":["Docket No. FDA-2017-N-2901"],"dockets":[],"document_number":"2017-12007","effective_on":"2017-08-08","end_page":26810,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2017/06/09/2017-12007.xml","html_url":"https://www.federalregister.gov/documents/2017/06/09/2017-12007/medical-devices-validated-instructions-for-use-and-validation-data-requirements-for-certain-reusable","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2017-12007?publication_date=2017-06-09","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2017-06-09/2017-12007/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":13001,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2017-06-09/pdf/2017-12007.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2017-12007.pdf?1496925949","publication_date":"2017-06-09","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2017/06/09/2017-12007.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-2017-N-2901","supporting_documents_count":0,"docket_id":"FDA-2017-N-2901","regulation_id_number":null,"title":"Medical Devices; Validated Instructions for Use and Validation Data Requirements for Certain Reusable Medical Devices in Premarket Notifications","checked_regulationsdotgov_at":"2017-06-29T06:00:28Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":26807,"subtype":null,"title":"Medical Devices; Validated Instructions for Use and Validation Data Requirements for Certain Reusable Medical Devices in Premarket Notifications","toc_doc":"Validated Instructions for Use and Validation Data Requirements for Certain Reusable Medical Devices in Premarket Notifications","toc_subject":"Medical Devices:","topics":[],"type":"Notice","volume":82}