{"id":982,"date":"2022-05-30T17:10:22","date_gmt":"2022-05-30T17:10:22","guid":{"rendered":"https:\/\/awrightpath.net\/?p=982"},"modified":"2022-10-28T20:03:10","modified_gmt":"2022-10-28T20:03:10","slug":"what-you-need-to-know-about-the-fda-510k-premarket-notification-process","status":"publish","type":"post","link":"https:\/\/awrightpath.net\/what-you-need-to-know-about-the-fda-510k-premarket-notification-process\/","title":{"rendered":"What You Need to Know About the FDA 510(k) Premarket Notification Process"},"content":{"rendered":"\r\n<p>So you want to get a new device on the market. How do you <a href=\"https:\/\/awrightpath.net\/\" rel=\"noreferrer noopener\" aria-label=\"undefined (opens in a new tab)\">start the approval process<\/a>? An FDA 510(k) (Food and Drug Administration) premarket notification grants you the ability to market your medical device in the United States. But before you can submit a notification, you have to know the class of your device because not all devices need to submit an FDA 510(k).<!--more--><\/p>\r\n\r\n\r\n\r\n<h2>Medical Device Classification<\/h2>\r\n\r\n\r\n\r\n<p>Before you can get your medical device cleared\/approved, you must determine your regulatory strategy. This helps define the regulatory path you must take. Part of this process is classifying your medical device between Class 1, Class 2 or Class 3.<\/p>\r\n\r\n\r\n\r\n<p>Medical devices are placed into three different classes to better address regulatory requirements and the risk level of the device. Medical devices are classified by the Center for Devices and Radiological Health (CDRH) at FDA from certain criteria, including risk, invasiveness, and impact on patient health. Some exclusions apply in each classification making a premarket notification not needed.<\/p>\r\n\r\n\r\n\r\n<h3 style=\"padding-left: 40px;\">Class I Devices<\/h3>\r\n\r\n\r\n\r\n<p style=\"padding-left: 40px;\">Class I devices are the fastest and easiest group to bring to market. They have the lowest risk to the patient and are not intended to support or sustain life. 47% of\u00a0medical devices\u00a0on the market fall under Class I (source:\u00a0<a href=\"https:\/\/www.fda.gov\/medical-devices\/consumers-medical-devices\/learn-if-medical-device-has-been-cleared-fda-marketing\" target=\"_blank\" rel=\"noreferrer noopener\">fda.gov<\/a>), but the majority are exempt from the regulatory process.<\/p>\r\n\r\n\r\n\r\n<h4 style=\"padding-left: 40px;\">Class I Devices Include:<\/h4>\r\n\r\n\r\n\r\n<ul>\r\n<li style=\"list-style-type: none;\">\r\n<ul>\r\n<li>Cot<\/li>\r\n<li>Standard Wheelchair<\/li>\r\n<li>Oxygen Mask<\/li>\r\n<li>Electric Toothbrush<\/li>\r\n<li>Bandages and Gauze<\/li>\r\n<li>Manual Stethoscopes<\/li>\r\n<li>Protective Restraints<\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>\r\n\r\n\r\n\r\n<h3 style=\"padding-left: 40px;\">Class II Devices<\/h3>\r\n\r\n\r\n\r\n<p style=\"padding-left: 40px;\">Most reviewed and approved devices on the market are considered\u00a0Class II. They are slightly more complicated than Class I and have a higher risk. They typically have sustained contact with patients, sometimes coming into contact with a patient\u2019s cardiovascular system or internal organs.\u00a0<\/p>\r\n\r\n\r\n\r\n<p style=\"padding-left: 40px;\">Class II\u00a0is subject to more than just general controls like device performance, postmarket surveillance,\u00a0labeling, and premarket data. By\u00a0Class II\u00a0definition, these general controls are insufficient to provide reasonable assurance of the device\u2019s safety and effectiveness. Because of this,\u00a0Class II\u00a0is also subject to\u00a0special controls, including special\u00a0labeling\u00a0requirements, patient registries, and performance standards.<\/p>\r\n\r\n\r\n\r\n<h4 style=\"padding-left: 40px;\">Class II Devices Include:<\/h4>\r\n\r\n\r\n\r\n<ul>\r\n<li style=\"list-style-type: none;\">\r\n<ul>\r\n<li>Blood Pressure Cuffs<\/li>\r\n<li>Surgical Gloves<\/li>\r\n<li>Contact Lenses<\/li>\r\n<li>Catheters and Syringes<\/li>\r\n<li>Powered Wheelchairs<\/li>\r\n<li>Pregnancy Tests<\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>\r\n\r\n\r\n\r\n<p style=\"padding-left: 40px;\">Class II\u00a0devices may be moved up to\u00a0Class III\u00a0if the\u00a0submitter\u00a0cannot provide\u00a0substantial equivalence\u00a0to a\u00a0predicate device. In these cases, a\u00a0<a href=\"https:\/\/www.fda.gov\/medical-devices\/premarket-submissions-selecting-and-preparing-correct-submission\/de-novo-classification-request\" target=\"_blank\" rel=\"noreferrer noopener\">De Novo\u00a0classification<\/a>\u00a0is a risk-based assessment that can help gain approval.\u00a0<\/p>\r\n\r\n\r\n\r\n<h3 style=\"padding-left: 40px;\">Class III Devices<\/h3>\r\n\r\n\r\n\r\n<p style=\"padding-left: 40px;\">Due to the strict\u00a0guidance for industry\u00a0standards,\u00a0Class III devices\u00a0only make up 10% of\u00a0medical devices\u00a0on the market. They typically support or sustain life, have a high-risk factor, or are implanted into the patient. This classification is generally reserved for permanent implants, smart\u00a0medical devices, and life support systems. This class of devices requires a\u00a0Pre-Market Approval\u00a0(PMA) submission to the\u00a0FDA.<\/p>\r\n\r\n\r\n\r\n<h4 style=\"padding-left: 40px;\">Class III Devices Include:<\/h4>\r\n\r\n\r\n\r\n<ul>\r\n<li style=\"list-style-type: none;\">\r\n<ul>\r\n<li>Pacemakers<\/li>\r\n<li>Implants\u00a0<\/li>\r\n<li>Ventilators<\/li>\r\n<li>Defibrillators<\/li>\r\n<li>Coronary Stents<\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>\r\n\r\n\r\n\r\n<p style=\"padding-left: 40px;\">For\u00a0additional information, reference\u00a0<a href=\"https:\/\/www.fda.gov\/industry\/fda-basics-industry\/guidances\" target=\"_blank\" rel=\"noreferrer noopener\">FDA guidance documents<\/a>.<\/p>\r\n\r\n\r\n\r\n<h2>What Is a Premarket Notification?<\/h2>\r\n\r\n\r\n\r\n<p>Depending on the class of your\u00a0medical device\u00a0and the determined regulatory pathway, you may need to submit a 510(k) that is not subject to\u00a0premarket approval. The\u00a0premarket notification\u00a0510(k) is a required regulatory submission to\u00a0FDA\u00a0for companies to market a\u00a0medical device\u00a0in the United States. The requirements are identified in Section 513 of the\u00a0<a href=\"https:\/\/www.fda.gov\/regulatory-information\/laws-enforced-fda\/federal-food-drug-and-cosmetic-act-fdc-act\" target=\"_blank\" rel=\"noreferrer noopener\">Federal Food, Drug, and Cosmetic Act<\/a>. A new 510(k) may be required when a change to the device affects safety, effectiveness, or\u00a0intended use.<\/p>\r\n\r\n\r\n\r\n<h2>Finding a Predicate Device<\/h2>\r\n\r\n\r\n\r\n<p>In order to have a successful premarket notification 510(k) submission, you must demonstrate that an already legally marketed device has substantial equivalence (SE) to your product and has the same intended use. Substantial equivalence does not mean identical! If an FDA 510(k) review finds that the device is not substantially equivalent (NSE), another regulatory pathway must be determined.<\/p>\r\n\r\n\r\n\r\n<p>FDA maintains an <a href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1998-02-02\/98-2498\" target=\"_blank\" rel=\"noreferrer noopener\">electronic database<\/a> of 510(k)s cleared by the FDA. This database is searchable by device classification, regulation number, 510(k) number, device name, applicant, product code, date 510(k) received, 510(k) decision date, decision summary and statement. The database also allows you to view details on premarket notifications to determine an appropriate predicate device for your 510(k) premarket notification submission to FDA.<\/p>\r\n\r\n\r\n\r\n<p>Predicate devices don\u2019t have to be exactly the same, but most similar for the device under review. The submitter must show the new device is at least as safe and effective as the predicate. Marketing clearance is easily given if shown to have the same intended use and technology. However, it may be cleared if it has the same intended use as the existing device, even if it has modern technological characteristics. U.S. Food and Drug Administration staff will clear the 510(k) as long as the device is as safe and effective as the predicate and raises no new questions of safety and effectiveness.<\/p>\r\n\r\n\r\n\r\n<h2>Need an FDA Interpreter?<\/h2>\r\n\r\n\r\n\r\n<p>When you\u2019ve found or invented the next great\u00a0medical device, don\u2019t let\u00a0FDA\u00a0regulations get in your way. At\u00a0<a href=\"https:\/\/awrightpath.net\/\">A Wright Path<\/a>, we can help you submit an\u00a0FDA\u00a0510(k)\u00a0premarket notification\u00a0and get your product to market as soon as possible. After approval, we have other long-term solutions to ensure your manufacturing and post-marketing processes always meet regulatory requirements and pass\u00a0FDA\u00a0inspections. Wherever you are in the process,\u00a0<a href=\"https:\/\/awrightpath.net\/contact\/\">schedule a consultation today<\/a>\u00a0to see how we can help.<\/p>\r\n","protected":false},"excerpt":{"rendered":"<p>So you want to get a new device on the market. How do you start the approval process? An FDA 510(k) (Food and Drug Administration) premarket notification grants you the ability to market your medical device in the United States. But before you can submit a notification, you have to know the class of your [&hellip;]<\/p>\n","protected":false},"author":7,"featured_media":983,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[9],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v20.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Understanding the FDA 510(k) Premarket Notification<\/title>\n<meta name=\"description\" content=\"Submitting an FDA 510(k) premarket notification depends on the classification of your medical device. 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