{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled \"Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation.\" FDA encourages the collection, analysis, and integration of patient perspectives in the development, evaluation, and surveillance of medical devices, including digital health technologies. Patient-reported outcome (PRO) instruments facilitate the systematic collection of patient perspectives as valid scientific evidence to support the regulatory and healthcare decision-making process. This guidance describes principles that should be considered when using PRO instruments in the evaluation of medical devices and provides recommendations about the importance of ensuring the measures are fit- for-purpose. This guidance is not meant to replace the Patient-Focused Drug Development (PFDD) guidance series. Some of the comments received in the docket may be addressed in PFDD Guidance #3, which is currently in development.","action":"Notice of availability.","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/2022/01/26/2022-01377.html","cfr_references":[],"citation":"87 FR 4033","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on January 26, 2022.","disposition_notes":null,"docket_ids":["Docket No. FDA-2020-D-1564"],"dockets":[],"document_number":"2022-01377","effective_on":null,"end_page":4035,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/01/26/2022-01377.xml","html_url":"https://www.federalregister.gov/documents/2022/01/26/2022-01377/principles-for-selecting-developing-modifying-and-adapting-patient-reported-outcome-instruments-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-01377?publication_date=2022-01-26","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-01-26/2022-01377/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":674,"last_updated":"2026-04-10 08:15:11 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-01-26/pdf/2022-01377.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-01377.pdf?1643118327","publication_date":"2022-01-26","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/01/26/2022-01377.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-D-1564","supporting_documents_count":0,"docket_id":"FDA-2020-D-1564","document_id":"FDA-2020-D-1564-0011","regulation_id_number":null,"title":"Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; Availability","checked_regulationsdotgov_at":"2022-01-27T04:30:05Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":4033,"subtype":null,"title":"Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation; Guidance for Industry and Food and Drug Administration Staff, and Other Stakeholders; Availability","toc_doc":"Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":87}