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 about the FDA medical device approval timeline — plus some tips on navigating the regulatory process with as few hurdles as possible.
Device Registration Process & Device Classification
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.
Device Classification
Class I Devices
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.
Class II Devices
Class II devices, on the other hand, usually require a premarket notification 510(k) application, where the manufacturer submits information about their device’s intended use. The manufacturer must demonstrate the device’s safety and efficacy through “substantial equivalence,” meaning that it is similar to a device already on the market (known as a predicate device).
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.
Class III Devices
Class III devices have the most stringent regulations because they are high risk, sustain a person’s life, or otherwise prevent impairment of someone’s 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.
De Novo Classification
The De Novo classification process is for new devices with no predicate (predecessor) device. The FDA will review the device’s 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.
FDA Guidance With A Wright Path
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.
Don’t go it alone! A Wright Path 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 — contact us today!
