{"id":6730,"date":"2026-05-27T14:26:19","date_gmt":"2026-05-27T08:56:19","guid":{"rendered":"https:\/\/operonstrategist.com\/?p=6730"},"modified":"2026-05-27T14:41:59","modified_gmt":"2026-05-27T09:11:59","slug":"humanitarian-device-exemption-hde","status":"publish","type":"post","link":"https:\/\/operonstrategist.com\/om-en\/humanitarian-device-exemption-hde\/","title":{"rendered":"Humanitarian Device Exemption (HDE) | FDA Rare Disease Pathway Explained"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"6730\" class=\"elementor elementor-6730\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9a68d45 e-flex e-con-boxed e-con e-parent\" data-id=\"9a68d45\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5777a2ec elementor-widget elementor-widget-heading\" data-id=\"5777a2ec\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Humanitarian Device Exemption (HDE) | FDA Rare Disease Pathway Explained<\/h2>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-780aaa20 e-flex e-con-boxed e-con e-parent\" data-id=\"780aaa20\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-1faf4577 e-con-full e-flex e-con e-child\" data-id=\"1faf4577\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3fc143aa elementor-widget elementor-widget-heading\" data-id=\"3fc143aa\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Introduction<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-14560235 elementor-widget elementor-widget-text-editor\" data-id=\"14560235\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">The Humanitarian Device Exemption (HDE) is a regulatory pathway established by the U.S. Food and Drug Administration (FDA). It allows medical devices intended for rare diseases or conditions to reach the U.S. market more easily. To qualify, the device must be designed for conditions affecting fewer than 8,000 individuals per year in the United States.<\/span><\/p><p><span style=\"font-weight: 400;\">Unlike the<\/span><a href=\"https:\/\/operonstrategist.com\/services\/regulatory-approvals\/fda-510k\/\"><span style=\"font-weight: 400;\"> FDA 510(k)<\/span><\/a><span style=\"font-weight: 400;\"> or <\/span><a href=\"https:\/\/operonstrategist.com\/510k-vs-pma\/\"><span style=\"font-weight: 400;\">Premarket Approval<\/span><\/a><span style=\"font-weight: 400;\"> (PMA) process, the HDE pathway does not require manufacturers to demonstrate full effectiveness. Instead, they must show that the device is safe and provides a probable benefit to patients.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-59b10acf e-con-full e-flex e-con e-child\" data-id=\"59b10acf\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-5de17c88 e-con-full e-flex e-con e-child\" data-id=\"5de17c88\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-71106852 elementor-widget elementor-widget-heading\" data-id=\"71106852\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Add Your Heading Text Here<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2d7bee5d elementor-widget elementor-widget-wpforms\" data-id=\"2d7bee5d\" 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) );\n\t\t\t\t\tdocument.head.appendChild( style );\n\t\t\t\t\tdocument.currentScript?.remove();\n\t\t\t\t} )();\n\t\t\t<\/script><\/div><!-- .wpforms-field-container --><div class=\"wpforms-submit-container\" ><input type=\"hidden\" name=\"wpforms[id]\" value=\"6203\"><input type=\"hidden\" name=\"page_title\" value=\"\"><input type=\"hidden\" name=\"page_url\" value=\"https:\/\/operonstrategist.com\/om-en\/wp-json\/wp\/v2\/posts\/6730\"><input type=\"hidden\" name=\"url_referer\" value=\"\"><button type=\"submit\" name=\"wpforms[submit]\" id=\"wpforms-submit-6203\" class=\"wpforms-submit\" data-alt-text=\"Sending...\" data-submit-text=\"Submit\" aria-live=\"assertive\" value=\"wpforms-submit\">Submit<\/button><img decoding=\"async\" src=\"https:\/\/operonstrategist.com\/wp-content\/plugins\/wpforms\/assets\/images\/submit-spin.svg\" class=\"wpforms-submit-spinner\" style=\"display: none;\" width=\"26\" height=\"26\" alt=\"Loading\"><\/div><\/form><\/div>  <!-- .wpforms-container -->\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-72d4bfc5 e-flex e-con-boxed e-con e-parent\" data-id=\"72d4bfc5\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-496317de elementor-widget elementor-widget-heading\" data-id=\"496317de\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">What is Humanitarian Device Exemption (HDE)?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6a68f5bf elementor-widget elementor-widget-text-editor\" data-id=\"6a68f5bf\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">The Humanitarian Device Exemption (HDE) program was created to encourage the development of medical devices for rare conditions where conducting large-scale clinical trials is difficult.<\/span><\/p><p><span style=\"font-weight: 400;\">Through this pathway, medical devices can be approved if:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The device is reasonably safe.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The probable benefit outweighs the potential risks.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The condition or disease affects a small patient population.<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">Before submitting an HDE application, manufacturers must obtain a Humanitarian Use Device (HUD) designation from the FDA\u2019s Office of Orphan Products Development (OOPD).<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7233112 elementor-widget elementor-widget-heading\" data-id=\"7233112\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Why HDE is Important?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a0a65f6 elementor-widget elementor-widget-text-editor\" data-id=\"a0a65f6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Without the HDE pathway, patients with rare conditions might never get medical devices tailored to their needs because it would be too costly or time-consuming for manufacturers to seek approval.<\/span><\/p><p><span style=\"font-weight: 400;\">HDE makes it possible for:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Patients to get early access to life-saving or life-improving devices.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Manufacturers to develop innovative solutions without the heavy burden of proving full clinical effectiveness.<\/span><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-91ea688 elementor-widget elementor-widget-heading\" data-id=\"91ea688\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Key FDA Requirements for HDE<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9c4697b elementor-widget elementor-widget-text-editor\" data-id=\"9c4697b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">To qualify for HDE approval, the following requirements must be met:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The disease or condition affects fewer than 8,000 patients annually in the U.S.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The device is not available under another FDA pathway.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">There is no comparable legally marketed device.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The probable benefit outweighs the risk of using the device.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The device is not intended for commercial profit, except under specific pediatric exceptions.<\/span><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-da60bfe elementor-widget elementor-widget-heading\" data-id=\"da60bfe\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">The HDE Application Process\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2692e73 elementor-widget elementor-widget-text-editor\" data-id=\"2692e73\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">The HDE submission and review process is similar to PMA (Premarket Approval) but requires less clinical data.<\/span><\/p><h3><span style=\"font-weight: 400;\">Steps include:<\/span><\/h3><ol><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">HUD Designation Request<\/span><span style=\"font-weight: 400;\"><br \/><\/span><span style=\"font-weight: 400;\">Submit a request to the FDA\u2019s Office of Orphan Products Development (OOPD) to classify the device as a Humanitarian Use Device.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Prepare HDE Application<\/span><span style=\"font-weight: 400;\"><br \/><\/span><span style=\"font-weight: 400;\">Provide safety data, manufacturing details, and information supporting probable patient benefit.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">FDA Review<\/span><span style=\"font-weight: 400;\"><br \/><\/span><span style=\"font-weight: 400;\">The FDA reviews the application within 75 days and evaluates whether the device meets all HDE requirements.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Approval and Post-Market Obligations<\/span><span style=\"font-weight: 400;\"><br \/><\/span><span style=\"font-weight: 400;\">Once approved, manufacturers must comply with post-market surveillance, annual reports, and labeling requirements.<\/span><\/li><\/ol>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3c7f583 elementor-widget elementor-widget-heading\" data-id=\"3c7f583\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Benefits of Humanitarian Device Exemption (HDE)\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c7e5904 elementor-widget elementor-widget-text-editor\" data-id=\"c7e5904\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Faster Approval: Devices can reach patients sooner since proof of effectiveness is not required.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Helps Rare Diseases: Provides treatment options for conditions affecting fewer than 8,000 people yearly.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Lower Costs: Requires less data than a full PMA, saving time and money.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Encourages Innovation: Motivates companies to develop devices for rare conditions.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Better Patient Access: Patients get solutions that may not otherwise be available.<\/span><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-74649a2 elementor-widget elementor-widget-heading\" data-id=\"74649a2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Challenges of Humanitarian Device Exemption (HDE)\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5dcd24c elementor-widget elementor-widget-text-editor\" data-id=\"5dcd24c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Small Patient Pool: Difficult to gather enough safety data because very few people are affected.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Profit Limits: Companies cannot sell HDE devices for profit (except for some pediatric cases).<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Monitoring Needed: Post-market safety checks are required, adding extra work.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Strict Eligibility: Only allowed if no similar device exists and benefits outweigh risks.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Extra Approvals: Hospitals need IRB approval before using these devices, which can slow access.<\/span><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-1250686f e-con-full e-flex e-con e-child\" data-id=\"1250686f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-187ca574 elementor-widget elementor-widget-heading\" data-id=\"187ca574\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">FAQ<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-29a8a442 elementor-widget elementor-widget-n-accordion\" data-id=\"29a8a442\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;all_collapsed&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-6980\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-6980\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> What is the main difference between HDE and 510(k)? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-6980\" class=\"elementor-element elementor-element-60379437 e-con-full e-flex e-con e-child\" data-id=\"60379437\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6482aaff elementor-widget elementor-widget-text-editor\" data-id=\"6482aaff\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">HDE is designed for rare diseases (&lt;8,000 patients per year) and requires proof of safety and probable benefit, while 510(k) requires showing equivalence to a legally marketed device.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-6981\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"2\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-6981\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Can HDE-approved devices be sold commercially? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-6981\" class=\"elementor-element elementor-element-56f820e0 e-con-full e-flex e-con e-child\" data-id=\"56f820e0\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-20c21995 elementor-widget elementor-widget-text-editor\" data-id=\"20c21995\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">No, except for certain pediatric devices, where limited profit may be allowed.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-6982\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"3\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-6982\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> How long does it take to get HDE approval? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-6982\" class=\"elementor-element elementor-element-6b1742ed e-con-full e-flex e-con e-child\" data-id=\"6b1742ed\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1f983659 elementor-widget elementor-widget-text-editor\" data-id=\"1f983659\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">The FDA typically reviews an HDE application within 75 days, though timelines may vary.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<script type=\"application\/ld+json\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"What is the main difference between HDE and 510(k)?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"HDE is designed for rare diseases (&lt;8,000 patients per year) and requires proof of safety and probable benefit, while 510(k) requires showing equivalence to a legally marketed device.\"}},{\"@type\":\"Question\",\"name\":\"Can HDE-approved devices be sold commercially?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"No, except for certain pediatric devices, where limited profit may be allowed.\"}},{\"@type\":\"Question\",\"name\":\"How long does it take to get HDE approval?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"The FDA typically reviews an HDE application within 75 days, though timelines may vary.\"}}]}<\/script>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Introduction The Humanitarian Device Exemption (HDE) is a regulatory pathway established by the U.S. Food and Drug Administration (FDA). It allows medical devices intended for rare diseases or conditions to reach the U.S. market more easily. To qualify, the device must be designed for conditions affecting fewer than 8,000 individuals per year in the United [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":6731,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[55],"tags":[],"class_list":["post-6730","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-regulatory"],"_links":{"self":[{"href":"https:\/\/operonstrategist.com\/om-en\/wp-json\/wp\/v2\/posts\/6730","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/operonstrategist.com\/om-en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/operonstrategist.com\/om-en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/om-en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/om-en\/wp-json\/wp\/v2\/comments?post=6730"}],"version-history":[{"count":0,"href":"https:\/\/operonstrategist.com\/om-en\/wp-json\/wp\/v2\/posts\/6730\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/om-en\/wp-json\/wp\/v2\/media\/6731"}],"wp:attachment":[{"href":"https:\/\/operonstrategist.com\/om-en\/wp-json\/wp\/v2\/media?parent=6730"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/operonstrategist.com\/om-en\/wp-json\/wp\/v2\/categories?post=6730"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/operonstrategist.com\/om-en\/wp-json\/wp\/v2\/tags?post=6730"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}