{"id":6457,"date":"2026-05-19T15:31:17","date_gmt":"2026-05-19T10:01:17","guid":{"rendered":"https:\/\/operonstrategist.com\/?p=6457"},"modified":"2026-05-19T17:32:01","modified_gmt":"2026-05-19T12:02:01","slug":"co-packaged-combination-product","status":"publish","type":"post","link":"https:\/\/operonstrategist.com\/us-en\/co-packaged-combination-product\/","title":{"rendered":"Co-packaged Combination Product"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"6457\" class=\"elementor elementor-6457\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-34998730 e-flex e-con-boxed e-con e-parent\" data-id=\"34998730\" 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-1871ff44 elementor-widget elementor-widget-heading\" data-id=\"1871ff44\" 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\">Co-packaged Combination Product<\/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-7b8741f4 e-flex e-con-boxed e-con e-parent\" data-id=\"7b8741f4\" 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-13f4654c e-con-full e-flex e-con e-child\" data-id=\"13f4654c\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-74b995bf elementor-widget elementor-widget-heading\" data-id=\"74b995bf\" 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\">Navigate Complex Drug-Device Regulations with Expert Support<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7b5db61d elementor-widget elementor-widget-text-editor\" data-id=\"7b5db61d\" 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;\">Bringing a co-packaged combination product to market requires precise regulatory classification, documentation alignment, and compliance with both drug and device regulations. At Operon Strategist, we help manufacturers like you simplify this complex process and ensure your product meets all regulatory requirements in the USA (FDA), India (CDSCO), and global markets.<\/span><\/p><p><span style=\"font-weight: 400;\">\ud83d\udce9 <\/span><a href=\"https:\/\/operonstrategist.com\/contact-us\/\"><span style=\"font-weight: 400;\">Contact Us Today<\/span><\/a><span style=\"font-weight: 400;\"> to begin your combination product compliance journey.<\/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-47ac3f51 e-con-full e-flex e-con e-child\" data-id=\"47ac3f51\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-3368202c e-con-full e-flex e-con e-child\" data-id=\"3368202c\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4988736c elementor-widget elementor-widget-heading\" data-id=\"4988736c\" 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-793f65af elementor-widget elementor-widget-wpforms\" data-id=\"793f65af\" 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=\"\/us-en\/wp-json\/wp\/v2\/posts\/6457\" data-token=\"79a083f905526ffeff35543e9571c185\" data-token-time=\"1779257846\"><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><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>\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\" >Text Name Email<\/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_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-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\/us-en\/wp-json\/wp\/v2\/posts\/6457\"><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-681587ad e-flex e-con-boxed e-con e-parent\" data-id=\"681587ad\" 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-44400980 elementor-widget elementor-widget-heading\" data-id=\"44400980\" 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 a Co-packaged Combination Product?\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-53a56904 elementor-widget elementor-widget-text-editor\" data-id=\"53a56904\" 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 co-packaged combination product consists of two or more individual components\u2014such as a drug and a device\u2014packaged together in a single unit but not chemically or physically combined. Delivery devices, bandages, and antibacterial swabs are all examples of device items. Understanding the regulations governing such a diverse range of devices can be difficult, hence drug companies frequently seek help from the device manufacturer \/provider before filing.<\/span><\/p>\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-4055f91 e-flex e-con-boxed e-con e-parent\" data-id=\"4055f91\" 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-d485cf1 elementor-widget elementor-widget-heading\" data-id=\"d485cf1\" 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\">Examples of co-packaged combination products :\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cc62586 elementor-widget elementor-widget-text-editor\" data-id=\"cc62586\" 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;\">One example of a co-packaged combination product is an inhaler with filled drug cartridge, which combines two components, an inhaler device and a drug, into a single container.\u00a0<\/span><\/p><ol><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Drug with delivery mechanism, i.e. nebulizer, inhaler, dropper or syringe\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Convenience kits i.e., first aid kits or surgery kits\u00a0<br \/><br \/><\/span><\/li><\/ol><p><span style=\"font-weight: 400;\">Previously, citing a specific device registration, such as a <\/span><a href=\"https:\/\/operonstrategist.com\/services\/regulatory-approvals\/fda-510k\/\"><span style=\"font-weight: 400;\">510(k)<\/span><\/a><span style=\"font-weight: 400;\">, was sufficient. Things have changed in recent years, with expectations extending far beyond a device\u2019s Design History File. It\u2019s important to think about how the device and medicine will work together as a \u201csystem.\u201d Functionality, compatibility, and human factors testing must show that the technology and medicine operate together to produce a positive result.\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">For the co-packaged combination product manufacturer implement streamlined approach which include drug and device by demonstrating compliance with either drug CGMPs 21CFR part 210 and 211 or Device QSR <\/span><a href=\"https:\/\/operonstrategist.com\/services\/turnkey-project\/quality-management-system\/fda-21-cfr-part820\/\"><span style=\"font-weight: 400;\">21CFR part 820<\/span><\/a><span style=\"font-weight: 400;\"> .To demonstrate the compliance manufacturer need to identify documents , many times manufacturer doesn\u2019t know how to create documents for the same, here our\u00a0 expert team\u00a0 help them by providing guidance for the correct QSR.<\/span><\/p><p><span style=\"font-weight: 400;\">The testing must account for the production and administration of a medicine using all of the intended components and resources. Any primary containment system components, such as vials and stoppers, as well as syringes, would fall under this category. When possible, testing should take into account the actual drug product, or the drug product plus diluent if a reconstitution step is required, and it should be done according to industry standards (ISO, USP, ASTM, etc.). However, not every device\/drug combination may have a standard.\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">In this situation, testing should be intended to evaluate all essential characteristics of the medication production and distribution process, and should, if possible, be based on or reference an industry standard.\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">Devices are more important than ever before in many drug applications. A co-packaged combination product must be examined as a whole, not only as individual components, and testing that verifies successful drug administration will be required. West has the unique knowledge and skills required for creating and performing studies to support co-packaged combination products as a global device developer and producer as well as a contract \u202fanalytical services\u202fprovider.\u00a0<\/span><\/p>\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-dc1c8ca e-flex e-con-boxed e-con e-parent\" data-id=\"dc1c8ca\" 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-a2ae2bc elementor-widget elementor-widget-heading\" data-id=\"a2ae2bc\" 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\">Types of Combination Product \n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-916683d elementor-widget elementor-widget-text-editor\" data-id=\"916683d\" 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 table below was constructed to identify and define the nine various types of combo products available. A package that contains only medical devices is not a combination product. Furthermore, a product that consists solely of medications is not a combination product. Contact your Centre\u2019s Product Jurisdiction Officer(s) if your product does not appear to satisfy one of the frequent instances below, or if you have questions about Forms 1571 and 365h about combination product categories.\u00a0<\/span><\/p><table><tbody><tr><td><p><span style=\"font-weight: 400;\">Type\u00a0\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Description\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Common Examples\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">1\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Convenience Kit or Co-Package\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">Drug and device are provided as individual constituent parts within the same package\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Convenience Kit or Co-Package\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">Manufacturers of co-packaged\u00a0 combination products that have a device constituent part must set up and maintain methods for imposing\u00a0 CAPA in accordancewith 21 CFR 820.100.<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">2\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Prefilled Drug Delivery Device\/ System\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">Drug is filled into or otherwise combined with the device AND the sole purpose of the device is to deliver drug\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Prefilled drug syringe, auto-injectors, metered-dose inhalers, dry powder inhalers, nasal spray etc.<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">3\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Prefilled Biologic Delivery Device\/ System\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">Biological product is filled into or otherwise combined with the device AND the only\u00a0 purpose of the device is to deliver biological product.<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Vaccine or other biological product in a prefilled syringe, auto-injector, nasal spray,<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">4\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Device Coated\/ Impregnated\/ Otherwise Combined with Drug\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">Device has an additional function in addition to delivering the drug\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Drug pills embedded with sensors, contact lens coated with a drug, drug-eluting stents, drug-eluting leads, condoms with spermicide, dental floss with fluoride<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">5\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Device Coated or Otherwise Combined with Biologic\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">Device has an additional function in addition to delivering the drug\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Live cells seeded on or in a device scaffold, extracorporeal column with column-bound protein\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">6\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Drug\/Biologic Combination\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Antibody-drug conjugates, progenitor cells combined with a drug to promote homing\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">7\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Separate Products Requiring Cross Labeling\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Light-activated drugs or biological products not co-packaged but labeled for use with a specific light source device\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">8\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Possible Combination Based on Cross Labeling of Separate Products\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Drug\/biological product under development utilizes a device, but\u202f\u202f unclear whether the final product will require that the two be cross-labeled\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">9\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Other Type of Part 3 Combination Product (e.g., Drug\/Device\/ Biological Product)\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">Combination product not otherwise described\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">All 3 articles are combined in a single product (e.g., a prefilled syringe containing an antibody-drug conjugate), device to manufacture a biologic also includes a drug or biologic in the kit, or the product contains two different combination product types (e.g., Type 1 and Type 2 are provided together\u00a0<\/span><\/p><\/td><\/tr><\/tbody><\/table><p><span style=\"font-weight: 400;\">The term combination product means the medical devices that contain medicinal product as an integral part, so to apply correct regulation to those can be challenging . Manufacturing and selling of medical devices need extensive research in regulatory domain but it is not possible for every manufacturer . As a <\/span><a href=\"https:\/\/operonstrategist.com\/\"><span style=\"font-weight: 400;\">medical device regulatory consultant<\/span><\/a><span style=\"font-weight: 400;\"> we guide them and provide regulatory services to make their road smooth.<\/span><\/p><p><span style=\"font-weight: 400;\">Reference: <\/span><a href=\"https:\/\/www.fda.gov\/media\/90425\/download\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">https:\/\/www.fda.gov\/media\/90425\/download<\/span><\/a><\/p>\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-33d7cf4 e-flex e-con-boxed e-con e-parent\" data-id=\"33d7cf4\" 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-9c41d8d elementor-widget elementor-widget-heading\" data-id=\"9c41d8d\" 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\">Regulatory Classification: FDA vs CDSCO\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bc14cd6 elementor-widget elementor-widget-text-editor\" data-id=\"bc14cd6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<h5><strong>US FDA (21 CFR Part 3 &amp; FD&amp;C Act)<\/strong><\/h5><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Co-packaged products are regulated by the Office of Combination Products (OCP).<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Classification is based on Primary Mode of Action (PMOA).<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">You may need to submit a Request for Designation (RFD) for clarity.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Must comply with both 21 CFR Part 210\/211 (Drugs) and <\/span><a href=\"https:\/\/operonstrategist.com\/elevateplus\/us-fda-510k-qsmr-registration\/\"><span style=\"font-weight: 400;\">21 CFR Part 820<\/span><\/a><span style=\"font-weight: 400;\"><span style=\"font-weight: 400;\"> (Devices).<\/span><\/span><p>\u00a0<\/p><\/li><\/ul><h5><strong>India CDSCO<\/strong><\/h5><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Governed by the Medical Device Rules (MDR), 2017 and New Drugs and Clinical Trial (NDCT) Rules, 2019.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">CDSCO requires clarity on whether the product is drug-led or device-led.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Proper classification determines the regulatory path and licensing requirements.<\/span><\/span><p>\u00a0<\/p><\/li><\/ul><p><span style=\"font-weight: 400;\">Need help determining your product\u2019s regulatory path? Let us assess your PMOA and provide strategic guidance.<\/span><\/p>\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-d972e3a e-flex e-con-boxed e-con e-parent\" data-id=\"d972e3a\" 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-14c9c40 elementor-widget elementor-widget-heading\" data-id=\"14c9c40\" 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 Challenges in Co-Packaged Product Compliance\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c51eaf3 elementor-widget elementor-widget-text-editor\" data-id=\"c51eaf3\" 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;\">Determining primary mode of action (PMOA)<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Harmonizing drug and device documentation standards<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Addressing usability engineering and human factors testing<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Managing dual QMS compliance (GMP + <\/span><a href=\"https:\/\/operonstrategist.com\/elevateplus\/quality-management-system-qms\/\"><span style=\"font-weight: 400;\">ISO 13485<\/span><\/a><span style=\"font-weight: 400;\">)<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Developing compliant labels and IFUs for combined use<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Navigating lengthy submission timelines without delays<\/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-e545036 e-flex e-con-boxed e-con e-parent\" data-id=\"e545036\" 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-3144300 elementor-widget elementor-widget-heading\" data-id=\"3144300\" 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 Choose Operon Strategist?\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-48d0bff elementor-widget elementor-widget-text-editor\" data-id=\"48d0bff\" 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;\">Global Regulatory Expertise \u2013 Experience with <\/span><a href=\"https:\/\/operonstrategist.com\/elevateplus\/us-fda-510k-qsmr-registration\/\"><span style=\"font-weight: 400;\">FDA<\/span><\/a><span style=\"font-weight: 400;\">, <\/span><a href=\"https:\/\/operonstrategist.com\/elevateplus\/cdsco-india\/\"><span style=\"font-weight: 400;\">CDSCO<\/span><\/a><span style=\"font-weight: 400;\">, <\/span><a href=\"https:\/\/operonstrategist.com\/elevateplus\/ce-marking-eu-mdr-ivdr\/\"><span style=\"font-weight: 400;\">EU-MDR<\/span><\/a><span style=\"font-weight: 400;\">, and more<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\"><a href=\"https:\/\/operonstrategist.com\/buildnext\/\">Turnkey Solutions<\/a> \u2013 From strategy to post-market support<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Multidisciplinary Team \u2013 Regulatory and quality experts<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Client-Centric Approach \u2013 Customized pathways for startups &amp; enterprises<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Trusted Partner \u2013 500+ successful projects across 12+ countries<br \/><br \/><\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">We don\u2019t just consult \u2014 we partner with you to get your product compliant, approved, and to market.<\/span><\/p>\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-5b28875e e-con-full e-flex e-con e-child\" data-id=\"5b28875e\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-786c9135 elementor-widget elementor-widget-heading\" data-id=\"786c9135\" 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-74914e49 elementor-widget elementor-widget-n-accordion\" data-id=\"74914e49\" 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-1950\" 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-1950\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> What is a co-packaged combination product? <\/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-1950\" class=\"elementor-element elementor-element-3d3dd8be e-con-full e-flex e-con e-child\" data-id=\"3d3dd8be\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1db59147 elementor-widget elementor-widget-text-editor\" data-id=\"1db59147\" 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 data-start=\"108\" data-end=\"421\">A co-packaged combination product contains two or more regulated components, such as a drug and a medical device, packaged together in a single unit but not physically or chemically combined. Common examples include inhalers with drug cartridges, prefilled syringes, nebulizer kits, and surgical convenience kits.<\/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-1951\" 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-1951\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> How does the FDA classify co-packaged combination products? <\/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-1951\" class=\"elementor-element elementor-element-16ef00d4 e-con-full e-flex e-con e-child\" data-id=\"16ef00d4\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-93128d9 elementor-widget elementor-widget-text-editor\" data-id=\"93128d9\" 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 data-start=\"487\" data-end=\"750\">The <span class=\"hover:entity-accent entity-underline inline cursor-pointer align-baseline\"><span class=\"whitespace-normal\">U.S. Food and Drug Administration<\/span><\/span> classifies co-packaged combination products based on their Primary Mode of Action (PMOA). The Office of Combination Products (OCP) determines whether the product will follow a drug, device, or biologic regulatory pathway.<\/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-1952\" 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-1952\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> What is Primary Mode of Action (PMOA)? <\/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-1952\" class=\"elementor-element elementor-element-494f9082 e-con-full e-flex e-con e-child\" data-id=\"494f9082\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-17bd80d1 elementor-widget elementor-widget-text-editor\" data-id=\"17bd80d1\" 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 data-start=\"795\" data-end=\"1031\">PMOA refers to the main therapeutic action that provides the product\u2019s intended effect. Determining PMOA is essential because it defines the lead regulatory center and the applicable compliance requirements for your combination product.<\/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-1953\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"4\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1953\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> What regulations apply to co-packaged combination products in the USA? <\/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-1953\" class=\"elementor-element elementor-element-1a603d01 e-con-full e-flex e-con e-child\" data-id=\"1a603d01\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-796e3d5 elementor-widget elementor-widget-text-editor\" data-id=\"796e3d5\" 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 data-start=\"1108\" data-end=\"1178\">Manufacturers may need to comply with multiple regulations, including:<\/p><ul data-start=\"1179\" data-end=\"1354\"><li data-section-id=\"11leqtk\" data-start=\"1179\" data-end=\"1230\">21 CFR Part 210 and 211 for drug GMP requirements<\/li><li data-section-id=\"mmd5dg\" data-start=\"1231\" data-end=\"1299\">21 CFR Part 820 for medical device Quality System Regulation (QSR)<\/li><li data-section-id=\"1yr6p4n\" data-start=\"1300\" data-end=\"1354\">FDA combination product guidance under 21 CFR Part 3<\/li><\/ul>\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 a co-packaged combination product?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"A co-packaged combination product contains two or more regulated components, such as a drug and a medical device, packaged together in a single unit but not physically or chemically combined. 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At Operon Strategist, we help manufacturers like you simplify this complex process and ensure your product meets all regulatory requirements in the USA (FDA), India (CDSCO), and [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":6464,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[16],"tags":[],"class_list":["post-6457","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-device-manufacturing"],"_links":{"self":[{"href":"https:\/\/operonstrategist.com\/us-en\/wp-json\/wp\/v2\/posts\/6457","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/operonstrategist.com\/us-en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/operonstrategist.com\/us-en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/us-en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/us-en\/wp-json\/wp\/v2\/comments?post=6457"}],"version-history":[{"count":0,"href":"https:\/\/operonstrategist.com\/us-en\/wp-json\/wp\/v2\/posts\/6457\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/us-en\/wp-json\/wp\/v2\/media\/6464"}],"wp:attachment":[{"href":"https:\/\/operonstrategist.com\/us-en\/wp-json\/wp\/v2\/media?parent=6457"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/operonstrategist.com\/us-en\/wp-json\/wp\/v2\/categories?post=6457"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/operonstrategist.com\/us-en\/wp-json\/wp\/v2\/tags?post=6457"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}