{"id":518,"date":"2026-01-07T16:05:52","date_gmt":"2026-01-07T20:05:52","guid":{"rendered":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/?p=518"},"modified":"2026-01-13T11:34:15","modified_gmt":"2026-01-13T15:34:15","slug":"fda-launches-the-tempo-pilot-for-digital-health-devices-to-improve-patient-access-to-technologies","status":"publish","type":"post","link":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2026\/01\/07\/fda-launches-the-tempo-pilot-for-digital-health-devices-to-improve-patient-access-to-technologies\/","title":{"rendered":"FDA Launches the TEMPO Pilot for Digital Health Devices to Improve Patient Access to Technologies"},"content":{"rendered":"\n<p>By <a href=\"https:\/\/www.duanemorris.com\/attorneys\/vickignorton.html\">Vicki G. Norton, Ph.d.<\/a>, <a href=\"https:\/\/www.duanemorris.com\/attorneys\/frederickrball.html\">Frederick R. Ball<\/a> and <a href=\"https:\/\/www.duanemorris.com\/attorneys\/victoriahawekotte.html\">Victoria (Tori) Hawekotte<\/a><\/p>\n\n\n\n<p>The U.S. Food and Drug Administration has announced the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, through which FDA would exercise enforcement discretion over participant manufacturers\u2019 digital health devices to improve patient access to digital health technologies. By exercising enforcement discretion, FDA would allow device manufacturers to forego certain marketing requirements, such as labeling and premarket authorization, while participating in the pilot program.<\/p>\n\n\n\n<p>Read the full <em><a href=\"https:\/\/www.duanemorris.com\/alerts\/fda_launches_tempo_pilot_digital_health_devices_improve_patient_access_technologies_0126.html\">Alert<\/a><\/em> on the Duane Morris LLP website.<\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>By Vicki G. Norton, Ph.d., Frederick R. Ball and Victoria (Tori) Hawekotte The U.S. Food and Drug Administration has announced the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, through which FDA would exercise enforcement discretion over participant manufacturers\u2019 digital health devices to improve patient access to digital health technologies. By exercising enforcement &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2026\/01\/07\/fda-launches-the-tempo-pilot-for-digital-health-devices-to-improve-patient-access-to-technologies\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;FDA Launches the TEMPO Pilot for Digital Health Devices to Improve Patient Access to Technologies&#8221;<\/span><\/a><\/p>\n","protected":false},"author":6,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2],"tags":[29,209,323,721],"ppma_author":[521],"class_list":["post-518","post","type-post","status-publish","format-standard","hentry","category-general","tag-fda","tag-frederick-ball","tag-medical-devices","tag-wearables"],"authors":[{"term_id":521,"user_id":6,"is_guest":0,"slug":"duanemorris3","display_name":"Duane Morris","avatar_url":"https:\/\/secure.gravatar.com\/avatar\/843ff6e7a8fe5fc92109b47a45f34b6cf0ea499e6e788db23456c838b0ae6747?s=96&d=blank&r=g","0":null,"1":"","2":"","3":"","4":"","5":"","6":"","7":"","8":""}],"_links":{"self":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/518","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/comments?post=518"}],"version-history":[{"count":0,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/518\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/media?parent=518"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/categories?post=518"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/tags?post=518"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/ppma_author?post=518"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}