{"id":4857,"date":"2025-11-20T10:20:36","date_gmt":"2025-11-20T17:20:36","guid":{"rendered":"https:\/\/www.kirtonmcconkie.com\/?post_type=km_practice_area&#038;p=4857"},"modified":"2026-04-08T10:45:41","modified_gmt":"2026-04-08T16:45:41","slug":"fda-regulatory-and-compliance","status":"publish","type":"km_practice_area","link":"https:\/\/www.kirtonmcconkie.com\/es\/practices\/fda-regulatory-and-compliance\/","title":{"rendered":"Normativa y cumplimiento de la FDA"},"content":{"rendered":"<style>\n    @media screen and (min-width: 768px) {\n        #hero-6a01e3a0806b0 .background-image  {\n            min-height: 600px;\n        }\n    }\n<\/style>\n\n<div id=\"hero-6a01e3a0806b0\" class=\"epic-hero-banner  mb-80\">\n        <div class=\"background-image\" style=\"background-image: url(https:\/\/www.kirtonmcconkie.com\/wp-content\/uploads\/2025\/11\/IMG_5220-scaled.jpg);\">\n                    <div class=\"background-overlay content-padding\" \n            style=\"background: rgba(14,25,76,0.1); justify-content: center; min-height: 600px;\"\n        >\n                                <div class=\"content frame\" style=\"align-items: flex-start;\">\n                <h2 class=\"text h1 canela animate fade-up\" style=\"color: #ffffff\">\n                    Normativa y cumplimiento de la FDA                <\/h2>\n                            <\/div>\n                            <\/div>\n            <\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-group is-layout-constrained wp-block-group-is-layout-constrained\">\n<h1 class=\"epic-heading h4 text-left animate fade-up metropolis  mb-20\" style=\"color:#DED8D0;transition-delay: 100ms;font-weight:200;\">\n    FDA Regulatory and Compliance Attorneys | Guiding Companies from Concept to Compliance<\/h1>\n\n<style>\n    #paragraph-6a01e3a080f28, #paragraph-6a01e3a080f28 p{\n        font-size: 20px;\n    }\n<\/style>\n<div id=\"paragraph-6a01e3a080f28\" class=\"epic-paragraph text-left big-line-height animate fade-up mb-40 mb-md-100\" style=\"color: #DED8D0; transition-delay:80ms;\"><p>Kirton McConkie\u2019s U.S. Food and Drug Administration (FDA) regulatory team guides emerging and established medical device, pharmaceutical, biotechnology, food, dietary supplement, nutraceutical, and cosmetic companies through every step of the FDA-regulated product lifecycle, including early-stage product development, pre-clinical and clinical trials, strategic interactions with regulators, premarket product approval and clearance pathways, and aftermarket compliance obligations.<\/p>\n<\/div>\n\n<style>\n    #paragraph-6a01e3a081261, #paragraph-6a01e3a081261 p{\n        font-size: 16px;\n    }\n<\/style>\n<div id=\"paragraph-6a01e3a081261\" class=\"epic-paragraph text-left  animate fade-up mb-20\" style=\"color: #DED8D0; transition-delay:80ms;\"><p>We leverage our team\u2019s extensive experience in government and industry, along with our extensive international network, to advise clients on complex FDA regulatory and compliance issues, including:<\/p>\n<\/div>\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\"><style>\n    #paragraph-6a01e3a0814c6, #paragraph-6a01e3a0814c6 p{\n        font-size: 16px;\n    }\n<\/style>\n<div id=\"paragraph-6a01e3a0814c6\" class=\"epic-paragraph text-left  animate fade-up mb-20\" style=\"color: #DED8D0; transition-delay:80ms;\"><ul>\n<li>Assisting companies developing innovative medical products (drugs, biologics, and medical devices) with regulatory strategy during early state development through FDA premarket submissions.<\/li>\n<li>Advising companies on FDA establishment registration and listing requirements.<\/li>\n<li>Guiding innovative medical device manufacturers through the Breakthrough Device Designation request process.<\/li>\n<li>Counseling medical device manufacturers on FDA premarket approval and clearance pathways, e.g., 510(k)s, de novos, premarket approvals (PMAs), and Emergency Use Authorizations (EUAs).<\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\"><style>\n    #paragraph-6a01e3a082d34, #paragraph-6a01e3a082d34 p{\n        font-size: 16px;\n    }\n<\/style>\n<div id=\"paragraph-6a01e3a082d34\" class=\"epic-paragraph text-left  animate fade-up mb-20\" style=\"color: #DED8D0; transition-delay:80ms;\"><ul>\n<li>Advising medical device companies with Quality System Regulation (QSR\/QSMR) and ISO 13485 compliance.<\/li>\n<li>Advising companies responding to FDA inspections and administrative actions (i.e., FDA 483s, warning letters, and untitled letters).<\/li>\n<li>Advising on medical device reporting (MDR) and product recall compliance.<\/li>\n<li>Negotiate with FDA\u2019s import officials and U.S. Customs and Boarder Protection (CBP) to secure the release of detained FDA-regulated products.<\/li>\n<li>Advise pharmaceutical and medical device clinical trial sponsors regarding listing compliance with clinicaltrials.gov reporting.<\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\"><style>\n    #paragraph-6a01e3a0830e1, #paragraph-6a01e3a0830e1 p{\n        font-size: 16px;\n    }\n<\/style>\n<div id=\"paragraph-6a01e3a0830e1\" class=\"epic-paragraph text-left  animate fade-up mb-50 mb-md-120\" style=\"color: #DED8D0; transition-delay:80ms;\"><ul>\n<li>Advising pharmaceutical and medical device manufacturers on state licensing and permit requirements.<\/li>\n<li>Advising food and food packaging companies on the regulatory status of food ingredients, generally recognized as safe (GRAS) submissions, dietary supplement ingredient notifications, and food contact substances and packaging materials.<\/li>\n<li>Assisting investors and investment funds with preliminary and ongoing due diligence surrounding portfolio companies and their transactional and licensing work.<\/li>\n<li>Assisting international manufacturers with their FDA-related obligations.<\/li>\n<\/ul>\n<\/div><\/div>\n<\/div>\n\n\n<style>\n    #paragraph-6a01e3a0834a9, #paragraph-6a01e3a0834a9 p{\n        font-size: 16px;\n    }\n<\/style>\n<div id=\"paragraph-6a01e3a0834a9\" class=\"epic-paragraph text-left  animate fade-up mb-20\" style=\"color: #DED8D0; transition-delay:80ms;\"><p>Our attorneys have held positions at the FDA and other federal agencies in Washington, DC, and on Capitol Hill and can provide effective counsel on FDA policy, legislative matters, and administrative governmental affairs. Our team has experience advising on federal, state, and local legislative strategies, writing comments on proposed rulemakings, and supporting clients with administrative hearings and panel meetings.<\/p>\n<p>&nbsp;<\/p>\n<p>We work closely with our corporate and international trade teams to advise on regulatory aspects of M&amp;A (mergers and acquisitions) transactions, and private equity and capital markets transactions. We also assist our clients with international product and precursor sourcing and supply chain restructuring, evaluating and procuring insurance, and conducting due diligence around the world. We also work with our litigation teams to defend against administrative overreach and medical device malpractice claims.<\/p>\n<\/div><\/div>\n\n\n<div class=\"container mt-50 mb-50 mt-md-100 mb-md-100\" style=\"width:100%\">\n    <hr class=\"animate grow-right\"  \/>\n<\/div>\n\n\n<div class=\"wp-block-group is-layout-constrained wp-block-group-is-layout-constrained\"><div class=\"contact-card animate fade-up\" style=\"transition-delay: 200ms;\">\n    <div class=\"row mb-30\">\n        <div class=\"col-12\">\n            <h5>Contactos de la pr\u00e1ctica<\/h5>\n        <\/div>\n    <\/div>\n    <div class=\"row cards-row align-items-center\">\n        <div class=\"card-img col-12 col-md-4\">\n                            <img decoding=\"async\" src=\"https:\/\/www.kirtonmcconkie.com\/wp-content\/uploads\/2025\/09\/Olson-Seth.jpg\" alt=\"J. Seth Olson\" class=\"img-fluid\">\n                    <\/div>\n        <div class=\"card-contact col-12 col-md-4\">\n            <div class=\"contact-item\">J. Seth Olson<\/div>\n                            <div class=\"contact-item\"> <a href=\"mailto:solson@kmclaw.com\">solson@kmclaw.com<\/a><\/div>\n                                        <div class=\"contact-item\"> <a href=\"tel:801.328.3600\">801.328.3600<\/a><\/div>\n                    <\/div>\n    <\/div>\n<\/div><\/div>\n\n\n<div class=\"container mt-50 mb-50 mt-md-100 mb-md-100\" style=\"width:100%\">\n    <hr class=\"animate grow-right\"  \/>\n<\/div>\n\n\n<div class=\"wp-block-group is-layout-constrained wp-block-group-is-layout-constrained\">\n<h5 class=\"epic-heading h5 text-left animate fade-up metropolis  mb-20\" style=\"color:#DED8D0;transition-delay: 100ms;font-weight:200;\">\n    Abogados en ejercicio<\/h5>\n\n<div class=\"cpt-cards animate fade-up\" style=\"transition-delay: 200ms;\">\n    <div class=\"row mb-30\"><\/div>\n\n    \n    <div class=\"row cpt-cards-row pl-2 pl-md-0\"\n         data-chunk=\"8\"\n         data-current-page=\"1\"\n         data-post-type=\"km_professionals\"\n         data-filter-by=\"practice_area\"\n         data-job-type=\"\"\n         data-location=\"\"\n         data-practice-area=\"4857\"\n         data-industry=\"\">\n\n                                                <div class=\"cpt-card col-12 col-md-3\">\n                    <button class=\"card-link pb-50 pb-md-80\" onclick=\"window.location.href='https:\/\/www.kirtonmcconkie.com\/es\/professionals\/joseph-brubaker\/';\">\n                        <div class=\"card-image-container\">\n                            <img decoding=\"async\" class=\"card-image mb-20\" src=\"https:\/\/www.kirtonmcconkie.com\/wp-content\/uploads\/2025\/07\/Brubaker-Joseph.jpg\" alt=\"\">\n                        <\/div>\n\n                        <h6 class=\"name\">Joseph R. Brubaker<\/h6>\n                        <div class=\"job-title mb-10\">Accionista<\/div>\n                        <hr class=\"animate my-10\">\n                                                    <div class=\"phone\"><a href=\"tel:8013283600\">801.328.3600<\/a><\/div>\n                            <hr class=\"animate my-10\">\n                                                <div class=\"contact-icons mb-10 mb-md-0\">\n                            <div class=\"icon email\"><a href=\"mailto:jbrubaker@kmclaw.com\"><i class=\"icon-envelope-o\"><\/i><\/a><\/div>\n                                                    <\/div>\n                        <a class=\"underline d-md-none\" href=\"https:\/\/www.kirtonmcconkie.com\/es\/professionals\/joseph-brubaker\/\">M\u00e1s informaci\u00f3n<\/a>\n                    <\/button>\n                <\/div>\n                            <div class=\"cpt-card col-12 col-md-3\">\n                    <button class=\"card-link pb-50 pb-md-80\" onclick=\"window.location.href='https:\/\/www.kirtonmcconkie.com\/es\/professionals\/jarom-harrison\/';\">\n                        <div class=\"card-image-container\">\n                            <img decoding=\"async\" class=\"card-image mb-20\" src=\"https:\/\/www.kirtonmcconkie.com\/wp-content\/uploads\/2025\/07\/Harrison-Jarom.jpg\" alt=\"\">\n                        <\/div>\n\n                        <h6 class=\"name\">Jarom M. Harrison<\/h6>\n                        <div class=\"job-title mb-10\">Asociado<\/div>\n                        <hr class=\"animate my-10\">\n                                                    <div class=\"phone\"><a href=\"tel:8013283600\">801.328.3600<\/a><\/div>\n                            <hr class=\"animate my-10\">\n                                                <div class=\"contact-icons mb-10 mb-md-0\">\n                            <div class=\"icon email\"><a href=\"mailto:jharrison@kmclaw.com\"><i class=\"icon-envelope-o\"><\/i><\/a><\/div>\n                                                    <\/div>\n                        <a class=\"underline d-md-none\" href=\"https:\/\/www.kirtonmcconkie.com\/es\/professionals\/jarom-harrison\/\">M\u00e1s informaci\u00f3n<\/a>\n                    <\/button>\n                <\/div>\n                            <div class=\"cpt-card col-12 col-md-3\">\n                    <button class=\"card-link pb-50 pb-md-80\" onclick=\"window.location.href='https:\/\/www.kirtonmcconkie.com\/es\/professionals\/seth-olson\/';\">\n                        <div class=\"card-image-container\">\n                            <img decoding=\"async\" class=\"card-image mb-20\" src=\"https:\/\/www.kirtonmcconkie.com\/wp-content\/uploads\/2025\/09\/Olson-Seth.jpg\" alt=\"\">\n                        <\/div>\n\n                        <h6 class=\"name\">J. Seth Olson<\/h6>\n                        <div class=\"job-title mb-10\">Accionista<\/div>\n                        <hr class=\"animate my-10\">\n                                                    <div class=\"phone\"><a href=\"tel:8013283600\">801.328.3600<\/a><\/div>\n                            <hr class=\"animate my-10\">\n                                                <div class=\"contact-icons mb-10 mb-md-0\">\n                            <div class=\"icon email\"><a href=\"mailto:solson@kmclaw.com\"><i class=\"icon-envelope-o\"><\/i><\/a><\/div>\n                                                    <\/div>\n                        <a class=\"underline d-md-none\" href=\"https:\/\/www.kirtonmcconkie.com\/es\/professionals\/seth-olson\/\">M\u00e1s informaci\u00f3n<\/a>\n                    <\/button>\n                <\/div>\n                            <div class=\"cpt-card col-12 col-md-3\">\n                    <button class=\"card-link pb-50 pb-md-80\" 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              <a href=\"https:\/\/www.kirtonmcconkie.com\/es\/practices\/corporate\/\"> Corporativo <\/a>\n                     <div class=\"icon\"><\/div>                <\/button>\n                <div id=\"cpt-accordion-0\" class=\"accordion-collapse collapse\" >\n                                            <ul class=\"practice-areas-list\">\n                                                            <li class=\"mb-10\"><a href=\"https:\/\/www.kirtonmcconkie.com\/es\/practices\/corporate\/business-formation-structure-and-exit-strategies\/\">Formaci\u00f3n, estructura y estrategias de salida de negocios<\/a><\/li>\n                                                            <li class=\"mb-10\"><a href=\"https:\/\/www.kirtonmcconkie.com\/es\/practices\/corporate\/contracts\/\">Contratos<\/a><\/li>\n                                                            <li class=\"mb-10\"><a href=\"https:\/\/www.kirtonmcconkie.com\/es\/practices\/corporate\/equipment-leasing\/\">Arrendamiento de equipos<\/a><\/li>\n                                                            <li class=\"mb-10\"><a href=\"https:\/\/www.kirtonmcconkie.com\/es\/practices\/corporate\/general-counsel-services\/\">Servicios de asesor\u00eda jur\u00eddica general<\/a><\/li>\n                                                            <li class=\"mb-10\"><a href=\"https:\/\/www.kirtonmcconkie.com\/es\/practices\/corporate\/internet-governance\/\">Gobernanza de Internet<\/a><\/li>\n                                                            <li class=\"mb-10\"><a href=\"https:\/\/www.kirtonmcconkie.com\/es\/practices\/corporate\/lending-and-finance\/\">Pr\u00e9stamos y finanzas<\/a><\/li>\n                                                            <li class=\"mb-10\"><a href=\"https:\/\/www.kirtonmcconkie.com\/es\/practices\/corporate\/mergers-and-acquisitions\/\">Fusiones y adquisiciones<\/a><\/li>\n                                                            <li class=\"mb-10\"><a href=\"https:\/\/www.kirtonmcconkie.com\/es\/practices\/corporate\/securities-law\/\">Ley de Valores<\/a><\/li>\n                                                    <\/ul>\n                                    <\/div>\n            <\/div>\n                    <div class=\"accordion-item\">\n                <button class=\"accordion-button collapsed equal-height-child\" id=\"heading-cpt-accordion\" type=\"button\" data-toggle=\"\" data-target=\"#cpt-accordion-1\">\n                    <a href=\"https:\/\/www.kirtonmcconkie.com\/es\/practices\/cybersecurity-and-data-privacy\/\"> Ciberseguridad y privacidad de datos <\/a>\n                                    <\/button>\n                <div id=\"cpt-accordion-1\" class=\"accordion-collapse collapse\" >\n                                    <\/div>\n            <\/div>\n                    <div class=\"accordion-item\">\n                <button class=\"accordion-button collapsed equal-height-child\" id=\"heading-cpt-accordion\" 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href=\"https:\/\/www.kirtonmcconkie.com\/es\/practices\/intellectual-property\/domain-name-disputes\/\">Conflictos sobre nombres de dominio<\/a><\/li>\n                                                            <li class=\"mb-10\"><a href=\"https:\/\/www.kirtonmcconkie.com\/es\/practices\/intellectual-property\/employee-contractor-intellectual-property-agreements\/\">Acuerdos de propiedad intelectual para empleados\/contratistas<\/a><\/li>\n                                                            <li class=\"mb-10\"><a href=\"https:\/\/www.kirtonmcconkie.com\/es\/practices\/intellectual-property\/intellectual-property-strategic-counsel\/\">Asesoramiento estrat\u00e9gico en materia de propiedad intelectual<\/a><\/li>\n                                                            <li class=\"mb-10\"><a href=\"https:\/\/www.kirtonmcconkie.com\/es\/practices\/intellectual-property\/licensing\/\">Licencias<\/a><\/li>\n                                                            <li class=\"mb-10\"><a href=\"https:\/\/www.kirtonmcconkie.com\/es\/practices\/intellectual-property\/patents\/\">Patentes<\/a><\/li>\n                                                            <li class=\"mb-10\"><a href=\"https:\/\/www.kirtonmcconkie.com\/es\/practices\/intellectual-property\/reissue-and-reexamination-of-patents\/\">Reedici\u00f3n y reexamen de patentes<\/a><\/li>\n                                                            <li class=\"mb-10\"><a href=\"https:\/\/www.kirtonmcconkie.com\/es\/practices\/intellectual-property\/trade-secrets\/\">Secretos comerciales<\/a><\/li>\n                                                            <li class=\"mb-10\"><a href=\"https:\/\/www.kirtonmcconkie.com\/es\/practices\/intellectual-property\/trademarks-service-marks-and-trade-dress\/\">Marcas comerciales, marcas de servicio e imagen comercial<\/a><\/li>\n                                                    <\/ul>\n                                    <\/div>\n            <\/div>\n 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href=\"https:\/\/www.kirtonmcconkie.com\/es\/practices\/international\/export-controls-sanctions-and-compliance\/\">Controles de exportaci\u00f3n, sanciones y cumplimiento normativo<\/a><\/li>\n                                                            <li class=\"mb-10\"><a href=\"https:\/\/www.kirtonmcconkie.com\/es\/practices\/international\/foreign-direct-investment\/\">Inversi\u00f3n extranjera directa<\/a><\/li>\n                                                            <li class=\"mb-10\"><a href=\"https:\/\/www.kirtonmcconkie.com\/es\/practices\/international\/global-migration-and-employment\/\">Migraci\u00f3n global y empleo<\/a><\/li>\n                                                            <li class=\"mb-10\"><a href=\"https:\/\/www.kirtonmcconkie.com\/es\/practices\/international\/international-dispute-resolution\/\">Resoluci\u00f3n de disputas internacionales<\/a><\/li>\n                                                            <li class=\"mb-10\"><a 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