{"id":128,"date":"2018-11-27T16:36:14","date_gmt":"2018-11-27T20:36:14","guid":{"rendered":"http:\/\/blogs.duanemorris.com\/lifescienceslaw\/?p=128"},"modified":"2018-11-27T16:36:14","modified_gmt":"2018-11-27T20:36:14","slug":"new-fda-draft-guidance-on-uncertainty-considerations-in-benefit-risk-determinations-for-medical-device-premarket-approvals","status":"publish","type":"post","link":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2018\/11\/27\/new-fda-draft-guidance-on-uncertainty-considerations-in-benefit-risk-determinations-for-medical-device-premarket-approvals\/","title":{"rendered":"New FDA Draft Guidance on Uncertainty Considerations in Benefit-Risk Determinations for Medical Device Premarket Approvals"},"content":{"rendered":"<p>The Food and Drug Administration recently issued draft guidance entitled \u201c<a href=\"https:\/\/www.fda.gov\/ucm\/groups\/fdagov-public\/@fdagov-meddev-gen\/documents\/document\/ucm619220.pdf\" target=\"_blank\" rel=\"noopener\">Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions<\/a>.\u201d Comments to this draft guidance should be provided by December 5, 2018.<\/p>\n<p>FDA provides authorization for marketing a device when its benefits outweigh its risks. Uncertainty surrounding these benefits and risks is a factor that FDA considers when making its determination with respect to premarket approval application (PMA) approvals,\u00a0<i>de novo<\/i>\u00a0classifications, 510(k) clearances, humanitarian device exemption (HDE) approvals and investigational device exemption approvals. As it has in previous guidances, FDA attempts to provide \u201ca flexible, patient-centric, benefit-risk approach\u201d that is \u201ctailored to the type and intended use of the device and the type of decision\u201d required. For example, PMA and\u00a0<i>de novo<\/i>\u00a0requests require a demonstration of reasonable assurance of safety and effectiveness. However, HDE applications inherently have a greater uncertainty surrounding the benefit-risk profile as Congress provided that these applications need not show a reasonable assurance of effectiveness as the patient population is generally very small.<\/p>\n<p><a href=\"https:\/\/www.duanemorris.com\/alerts\/fda_provides_guidance_uncertainty_considerations_benefit_risk_determinations_1118.html\">Visit the Duane Morris LLP website to read the full <em>Alert<\/em><\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Food and Drug Administration recently issued draft guidance entitled \u201cConsideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions.\u201d Comments to this draft guidance should be provided by December 5, 2018. FDA provides authorization for marketing a device when its benefits outweigh its risks. Uncertainty &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2018\/11\/27\/new-fda-draft-guidance-on-uncertainty-considerations-in-benefit-risk-determinations-for-medical-device-premarket-approvals\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;New FDA Draft Guidance on Uncertainty Considerations in Benefit-Risk Determinations for Medical Device Premarket Approvals&#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":[328,29,64,327,323,326,119],"ppma_author":[521],"class_list":["post-128","post","type-post","status-publish","format-standard","hentry","category-general","tag-de-novo","tag-fda","tag-guidance","tag-humanitarian-device","tag-medical-devices","tag-premarket-approval","tag-rick-ball"],"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\/128","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=128"}],"version-history":[{"count":0,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/128\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/media?parent=128"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/categories?post=128"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/tags?post=128"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/ppma_author?post=128"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}