{"id":1033,"date":"2022-10-19T10:31:34","date_gmt":"2022-10-19T15:31:34","guid":{"rendered":"https:\/\/awrightpath.net\/?p=1033"},"modified":"2023-02-02T10:35:10","modified_gmt":"2023-02-02T15:35:10","slug":"the-fda-medical-device-approval-timeline-how-long-does-it-take","status":"publish","type":"post","link":"https:\/\/awrightpath.net\/the-fda-medical-device-approval-timeline-how-long-does-it-take\/","title":{"rendered":"The FDA Medical Device Approval Timeline: How Long Does it Take?"},"content":{"rendered":"

The U.S. Food and Drug Administration (FDA)<\/a> regulates everything produced by drug and medical device companies. The FDA approval process is designed to ensure that every product on the market meets certain standards of safety and effectiveness. However, it can be confusing for anyone trying to navigate it independently. Here’s what you need to know about the FDA medical device approval timeline \u2014 plus some tips on navigating the regulatory process with as few hurdles as possible<\/a>.<\/p>\n

<\/p>\n

Device Registration Process & Device Classification<\/h2>\n

The first step in the medical device approval process is understanding device classification. The FDA recognizes three classes of healthcare devices: Class I, Class II, and Class III. Device classification is risk-based, with Class I devices being low risk, Class II devices being moderate risk, and Class III devices being high risk. The higher the class, the more regulation applies to the device.<\/p>\n

Device Classification<\/h3>\n

Class I Devices<\/h4>\n

Class I devices are typically the fastest to get market approval, sometimes in as little as a week depending on specific requirements on classification code. The submission process begins with paying the annual registration fee. The medical device manufacturer can then electronically submit their device and manufacturer information.<\/p>\n

Class II Devices<\/h4>\n

Class II devices, on the other hand, usually require a premarket notification 510(k) application, where the manufacturer submits information about their device\u2019s intended use. The manufacturer must demonstrate the device\u2019s safety and efficacy through \u201csubstantial equivalence,\u201d meaning that it is similar to a device already on the market (known as a predicate device).<\/p>\n

According to the FDA, the typical timeframe for FDA 510(k) approval is 90 days. Applicants can expect an acceptance review decision within 15 days and a substantive review decision in about 60 days. A final decision usually comes within 90 days. If there are review issues, the applicant is notified within 100 days. Keep in mind that this process can vary widely depending on the device type and may take 90 to 135 days depending on additional information requests from FDA; however, the device timeline may be reduced for medical devices eligible through third-party review.<\/p>\n

Class III Devices<\/h4>\n

Class III devices have the most stringent regulations because they are high risk, sustain a person\u2019s life, or otherwise prevent impairment of someone\u2019s health. Ventilators, defibrillators, and implanted devices like pacemakers are all Class III devices. These devices require premarket approval (PMA). The approval timeline varies based on clinical and non-clinical study requirements.<\/p>\n

De Novo Classification<\/h2>\n

The De Novo classification process<\/a> is for new devices with no predicate (predecessor) device. The FDA will review the device\u2019s safety and effectiveness as well as whether the device is substantially equivalent to a predicate device. Devices with the De Novo label may then be used as predicate devices for future premarket submissions. The De Novo classification process can take anywhere from six months to two years, depending on the complexity of your medical device.<\/p>\n

FDA Guidance With A Wright Path<\/h2>\n

The FDA review process can be a daunting prospect for developers in the medical device industry, but it’s important to know what to expect. The best way to do this is by keeping the FDA’s review timeline in mind as you plan your device development process, and knowing how different devices are approved will help you keep track of what needs doing and when.<\/p>\n

Don\u2019t go it alone! A Wright Path<\/a> can help you through the approval pathway and get your medical device to market without unnecessary delays. Go through the FDA medical device approval timeline as fast as possible \u2014\u00a0contact us today<\/a>!<\/p>\n","protected":false},"excerpt":{"rendered":"

The U.S. Food and Drug Administration (FDA) regulates everything produced by drug and medical device companies. The FDA approval process is designed to ensure that every product on the market meets certain standards of safety and effectiveness. However, it can be confusing for anyone trying to navigate it independently. Here’s what you need to know […]<\/p>\n","protected":false},"author":7,"featured_media":1034,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[8],"tags":[],"yoast_head":"\nWhat to Expect For the FDA Medical Device Approval Timeline<\/title>\n<meta name=\"description\" content=\"FDA approval for a medical device is a complex process \u2013 find out what to expect for the FDA medical device approval timeline.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/awrightpath.net\/the-fda-medical-device-approval-timeline-how-long-does-it-take\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"What to Expect For the FDA Medical Device Approval Timeline\" \/>\n<meta property=\"og:description\" content=\"FDA approval for a medical device is a complex process \u2013 find out what to expect for the FDA medical device approval timeline.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/awrightpath.net\/the-fda-medical-device-approval-timeline-how-long-does-it-take\/\" \/>\n<meta property=\"og:site_name\" content=\"A Wright Path | Right Path. 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