{"id":6676,"date":"2026-06-01T14:22:18","date_gmt":"2026-06-01T08:52:18","guid":{"rendered":"https:\/\/operonstrategist.com\/?p=6676"},"modified":"2026-06-02T11:53:55","modified_gmt":"2026-06-02T06:23:55","slug":"medical-device-accessories-guidance-food-drug-and-cosmetic-act","status":"publish","type":"post","link":"https:\/\/operonstrategist.com\/gb-en\/medical-device-accessories-guidance-food-drug-and-cosmetic-act\/","title":{"rendered":"Medical Device Accessories Guidance (Everything You Need To Know)"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"6676\" class=\"elementor elementor-6676\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4d5a1285 e-flex e-con-boxed e-con e-parent\" data-id=\"4d5a1285\" 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-2887c4e4 e-con-full e-flex e-con e-child\" data-id=\"2887c4e4\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2846b648 elementor-widget elementor-widget-heading\" data-id=\"2846b648\" 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\">Medical Device Accessories Guidance (Everything You Need To Know)<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-530ea23a elementor-widget elementor-widget-text-editor\" data-id=\"530ea23a\" 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 <\/span><a href=\"https:\/\/www.fda.gov\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">FDA<\/span><\/a><span style=\"font-weight: 400;\"> issued Medical Device Accessories \u2013Guidance for Industry and Food and Drug Administration Staff, which applies to the <\/span><a href=\"https:\/\/www.fda.gov\/AboutFDA\/CentersOffices\/OfficeofMedicalProductsandTobacco\/CDRH\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">Center for Devices and Radiological Health<\/span><\/a><span style=\"font-weight: 400;\"> (CDRH) and <\/span><a href=\"https:\/\/www.fda.gov\/AboutFDA\/CentersOffices\/OfficeofMedicalProductsandTobacco\/CBER\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">Center for Biologics Evaluation and Research<\/span><\/a><span style=\"font-weight: 400;\"> (CBER) for <\/span><span style=\"font-weight: 400;\">combination products<\/span><span style=\"font-weight: 400;\">.<\/span><\/p><p><span style=\"font-weight: 400;\">The #guidance document offers welcomed clarity on the role of an \u201caccessory\u201d and its regulatory relationship to its parent device. As always, guidance documents are not legally enforceable.<\/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-2f8c502d e-con-full e-flex e-con e-child\" data-id=\"2f8c502d\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-4a3e266c e-con-full e-flex e-con e-child\" data-id=\"4a3e266c\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-251be33d elementor-widget elementor-widget-heading\" data-id=\"251be33d\" 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\">talk to our experts<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-264c48a7 elementor-widget elementor-widget-wpforms\" data-id=\"264c48a7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"wpforms.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"wpforms-container wpforms-container-full wpforms-render-modern\" id=\"wpforms-6203\"><form id=\"wpforms-form-6203\" class=\"wpforms-validate wpforms-form wpforms-ajax-form\" data-formid=\"6203\" method=\"post\" enctype=\"multipart\/form-data\" action=\"\/gb-en\/wp-json\/wp\/v2\/posts\/6676\" data-token=\"a9cf6cd8d4000495d77213cf2045c3d0\" data-token-time=\"1780632555\"><noscript class=\"wpforms-error-noscript\">Please enable JavaScript in your browser to complete this form.<\/noscript><div id=\"wpforms-error-noscript\" style=\"display: none;\">Please enable JavaScript in your browser to complete this form.<\/div><div class=\"wpforms-field-container\"><div id=\"wpforms-6203-field_1-container\" class=\"wpforms-field wpforms-field-name\" data-field-id=\"1\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_1\" aria-hidden=\"false\">Name <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"text\" id=\"wpforms-6203-field_1\" class=\"wpforms-field-large wpforms-field-required\" name=\"wpforms[fields][1]\" placeholder=\"Name*\" aria-errormessage=\"wpforms-6203-field_1-error\" required><\/div><div id=\"wpforms-6203-field_2-container\" class=\"wpforms-field wpforms-field-email\" data-field-id=\"2\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_2\" aria-hidden=\"false\">Email <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"email\" id=\"wpforms-6203-field_2\" class=\"wpforms-field-large wpforms-field-required\" name=\"wpforms[fields][2]\" placeholder=\"Email*\" spellcheck=\"false\" aria-errormessage=\"wpforms-6203-field_2-error\" required><\/div>\t\t<div id=\"wpforms-6203-field_5-container\"\n\t\t\tclass=\"wpforms-field wpforms-field-text\"\n\t\t\tdata-field-type=\"text\"\n\t\t\tdata-field-id=\"5\"\n\t\t\t>\n\t\t\t<label class=\"wpforms-field-label\" for=\"wpforms-6203-field_5\" >Phone Text Name<\/label>\n\t\t\t<input type=\"text\" id=\"wpforms-6203-field_5\" class=\"wpforms-field-medium\" name=\"wpforms[fields][5]\" >\n\t\t<\/div>\n\t\t<div id=\"wpforms-6203-field_3-container\" class=\"wpforms-field wpforms-field-phone\" data-field-id=\"3\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_3\" aria-hidden=\"false\">Phone <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"tel\" id=\"wpforms-6203-field_3\" class=\"wpforms-field-large wpforms-field-required wpforms-smart-phone-field\" data-rule-smart-phone-field=\"true\" name=\"wpforms[fields][3]\" placeholder=\"Phone*\" aria-label=\"Phone\" aria-errormessage=\"wpforms-6203-field_3-error\" required><\/div><div id=\"wpforms-6203-field_4-container\" class=\"wpforms-field wpforms-field-textarea\" data-field-id=\"4\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_4\" aria-hidden=\"false\">Paragraph Text <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><textarea id=\"wpforms-6203-field_4\" class=\"wpforms-field-medium wpforms-field-required\" name=\"wpforms[fields][4]\" placeholder=\"Message\" aria-errormessage=\"wpforms-6203-field_4-error\" required><\/textarea><\/div><script>\n\t\t\t\t( function() {\n\t\t\t\t\tconst style = document.createElement( 'style' );\n\t\t\t\t\tstyle.appendChild( document.createTextNode( '#wpforms-6203-field_5-container { position: absolute !important; overflow: hidden !important; display: inline !important; height: 1px !important; width: 1px !important; z-index: -1000 !important; padding: 0 !important; } #wpforms-6203-field_5-container input { visibility: hidden; } #wpforms-conversational-form-page #wpforms-6203-field_5-container label { counter-increment: none; }' ) );\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-recaptcha-container wpforms-is-recaptcha wpforms-is-recaptcha-type-v3\" ><input type=\"hidden\" name=\"wpforms[recaptcha]\" value=\"\"><\/div><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\/gb-en\/wp-json\/wp\/v2\/posts\/6676\"><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-f23d990 e-flex e-con-boxed e-con e-parent\" data-id=\"f23d990\" 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-3f030b4c e-con-full e-flex e-con e-child\" data-id=\"3f030b4c\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6b25b781 elementor-widget elementor-widget-text-editor\" data-id=\"6b25b781\" 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 guidance explains which devices FDA generally considers \u201caccessories\u201d and describes the processes under Section 513(f)(6) of the Federal Food, Drug, and Cosmetic Act (FD&amp;C Act) to allow requests for risk- and regulatory control-based classification of medical device accessories.<\/span><\/p><p><span style=\"font-weight: 400;\">The updated guidance was derived from an August 2017 amendment to section 513(f) of the FD&amp;C Act (FDA Reauthorization Act of 2017.<\/span><\/p><p><span style=\"font-weight: 400;\">The amendment allows for some accessories to have a lower risk profile than that of their parent device. As classifications for accessories are now risk-based, it provides manufacturers with the <\/span><span style=\"font-weight: 400;\">regulatory<\/span><span style=\"font-weight: 400;\"> flexibility to loosen some of the regulatory burdens on accessories that may not have the same risk profile as their parent devices.<\/span><\/p><p><span style=\"font-weight: 400;\">For example, an accessory to a class III parent device may pose lower risk that could be mitigated through general controls, or a combination of general and special controls, and thus could be regulated as class I or class II. A common example of this would be a ventilation system (parent device) with a face mask (accessory).<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-59148ded elementor-widget elementor-widget-heading\" data-id=\"59148ded\" 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\">Guidance details within Section IV are mentioned below:\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-308d047f elementor-widget elementor-widget-text-editor\" data-id=\"308d047f\" 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;\">Accessory \u2014 \u201cA finished device that is intended to support, supplement, and\/or augment the performance of one or more parent devices.\u201d<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Component (21 CFR 820.3(c)) \u2014 \u201cAny raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device.\u201d<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Finished Device (21 CFR 820.3(l)) \u2014 \u201cAny device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.\u201d<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Parent Device \u2014 \u201cA finished device whose performance is supported, supplemented, and\/or augmented by one or more accessories.\u201d<\/span><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f616257 elementor-widget elementor-widget-heading\" data-id=\"f616257\" 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\">Accessory Classification Policy\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-50c8898c elementor-widget elementor-widget-text-editor\" data-id=\"50c8898c\" 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 risks of an accessory are the risks it presents when used with the corresponding parent device as intended.<\/span><\/p><p><span style=\"font-weight: 400;\">Once Medical Device Accessories are classified, there is another consideration manufacturers need to decide: the Unique Device Identifier (UDI) rule. Not only does your parent device need to have a UDI, but any and all accessories each need to be assigned a UDI.<\/span><\/p><p><span style=\"font-weight: 400;\">As <\/span><a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfCFR\/CFRSearch.cfm?CFRPart=830\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">21 CFR<\/span><\/a><span style=\"font-weight: 400;\"> 801 Labeling, Subpart B, Section 801.20(a) states: \u201c(1) The label of every medical device shall bear a unique device identifier (UDI) that meets the requirements of this subpart and part 830 of this chapter,\u201d and \u201c(2) Every device package shall bear a UDI that meets the requirements of this subpart and part 830 of this chapter.\u201d<\/span><\/p><p><span style=\"font-weight: 400;\">Further, <\/span><span style=\"font-weight: 400;\">21 CFR Part 830<\/span><span style=\"font-weight: 400;\"> UDI, Subpart A, Section 830.3 defines \u201cfinished device\u201d and \u201cdevice package\u201d as follows:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Finished device means any device or accessory to any device that is suitable for use or capable of functioning.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Device package means a package that contains a fixed quantity of a particular version or model of a device.<\/span><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ce30f24 elementor-widget elementor-widget-heading\" data-id=\"ce30f24\" 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 Does this Ultimately Mean for Manufacturers?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b2cb467 elementor-widget elementor-widget-text-editor\" data-id=\"b2cb467\" 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;\">A gap analysis should be performed to identify a thorough and complete list of your current and future medical device accessories to determine applicability to the guidance document. Justification also should be documented, should an accessory not apply to the guidance document. Additionally, internal procedures and the process associated with assigning UDIs may need to be updated to ensure there are no compliance gaps.<\/span><\/p>\t\t\t\t\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\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>The FDA issued Medical Device Accessories \u2013Guidance for Industry and Food and Drug Administration Staff, which applies to the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) for combination products. The #guidance document offers welcomed clarity on the role of an \u201caccessory\u201d and its regulatory relationship to its [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":7065,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[16],"tags":[],"class_list":["post-6676","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-device-manufacturing"],"_links":{"self":[{"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/posts\/6676","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/comments?post=6676"}],"version-history":[{"count":0,"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/posts\/6676\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/media\/7065"}],"wp:attachment":[{"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/media?parent=6676"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/categories?post=6676"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/tags?post=6676"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}