First, congratulations on creating a marketable and perhaps life saving device. Now, it’s time to get your product safely and effectively to market. But first you’ll need FDA clearance or approval and that requires getting through the FDA application process. Let’s break it down step by step.
Step 1. Understand the FDA
First, understanding the role of the FDA goes a long way in getting FDA approval. Above all, the FDA keeps the public safe. As such, key responsibilities of the organization include regulating design, production, and post-market activities. In addition, they continue to monitor the safety and effectiveness of medical devices and pharmaceuticals. Before your medical device can be sold in the U.S, you must obtain clearance or approval from the FDA for your specific device classifications. However, if you desire to sell your product outside the U.S., you’ll have similar regulations and guidelines from the target legal authorities.
Step 2. Identify Device Class
Second, identify your device class. In brief, the FDA categorizes medical devices into three classes based on risk to the patient, healthcare practitioners, and other users. Similarly, most global authorities use a similar risk-based approach. The FDA uses a three tiered system: Class I, Class II, and Class III.
The Categories Defined
Class I devices pose lower risk of harm. Class I devices are typically less complex in design and usually subject to general controls (with some exceptions). They make up 47 percent of U.S. medical devices. Typically, Class I devices do not require premarket clearance by the FDA. However, other pre-and post-market requirements may apply.
Class II devices are more complex because they pose a moderate risk and are therefore subject to both general and special controls. Class II devices comprise 43 percent of all U.S. medical devices. Special controls include performance standards for the device type, post-market surveillance, special labeling requirements, and premarket data requirements. Many Class II devices require Premarket Notification, 510(k) clearance before marketing the device in the United States.
Class III are high-risk and usually sustain or support life. Class III may be implantable or pose a potential unreasonable risk of illness or injury. They make up the remaining 10 percent of medical devices. Due to high-risk, such devices require a Pre-Market Approval (PMA) before marketing in the United States. The PMA must demonstrate valid scientific evidence from clinical trials that the device is safe and effective for its intended use and design.
Step 3. Create a Regulatory Strategy
In brief, you need to consult a regulatory specialist in order to develop a regulatory strategy. Above all, the regulatory specialist helps you determine your regulatory strategy which includes what you must provide to FDA with the specific documentation, testing, and reporting to get your particular medical device clearance to sale by the FDA. In fact, regulatory specialists help you build the product dossier for submission, review and final clearance or approval by the FDA.
Step 4. Build a Design History File
As you build the product dossier with documentation, you will also need a Design History File (DHF) to meet FDA’s requirements under 21 CFR 820. In short, the DHF contains all the product design and development documentation for a finished medical device. In fact, much of that documentation support your pre-market submission. The creation of the DHF is an on-going part of the design controls process directed and managed by your Quality System. Most importantly, your DHF works best as an organizational tool to show FDA that you established and followed your design control processes throughout product development.
Step 5. Get Real with Your Timeline
Finally, get real with your timeline. To illustrate, an annual review of 510(k) applications (Period 2012 to 2017) showed the average length of time to FDA clearance in 2016 was 191 days, with a 19 percent chance of device clearance in three months, and a 58 percent chance in six months. However, PMA applications took much longer for approval, as expected: with an average of 243 days in 2019.
Although many applications are cleared, the FDA frequently sends letters of deficiency to applicants who have not provided sufficient information within their pre-market notification. In fact, if the issues are not resolved within the 180-day timeline, the FDA can formally withdraw your 510(k) with no refund issued with the 510(k) user fee.
To avoid such risk, both regulatory and financial, invest in a high-quality and experienced team with the right quality and regulatory expertise from the beginning. With the right help, your FDA application process can be both timely and cost-effective.
Need help with your FDA application? Contact MAE Group today.