Physicians and consumers want to have confidence in the products they promote, purchase, or use, making FDA approval process a top priority for medical device companies. When a product reaches the market place, FDA approval lets people know that it is not just safe, but also effective for its intended use. To obtain FDA approval, companies need to submit their device or equipment through the FDA’s Center for Devices and Radiological Health (CDRH), which is responsible for regulating firms that manufacture, repackage, relabel, and/or import medical devices sold in the United States.
Unfortunately, bringing a device to market with FDA approval isn’t always easy—or fast. Science Direct shows that it can take an average of 3 to 7 years, and as a medical device startup, you may not be able to wait that long!
7 Ways to Expedite the FDA Approval Process
While you want to be sure your product is both safe and effective, there are still some ways that you may be able to accelerate FDA approval without cutting any corners. Here are seven ways to expedite the FDA approval process for your medical device.
1. Understand Your Device Class
The FDA places medical devices and equipment into three classes and depending on your class of equipment, obtaining approval could be a quick process—or a lengthy one. Approval for Class I and II devices, those that present “low to moderate risk of illness or injury,” are focused on registration, manufacturing, and labeling and often do not require extensive pre-clinical or clinical data. Class III devices, those which “support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential, unreasonable risk of illness or injury,” are more heavily scrutinized.
If your medical device is a Class I or II, you may be “exempt,” meaning there’s no need for proof of safety or efficacy, or clinical trials. If you’re Class III, however, you’ll typically need pre-market approval (PMA), the most rigorous process required for devices by the FDA. Understanding which class your medical device falls within can help you to better prepare for the FDA approval process.
2. Avoid Documentation Errors
For expedited FDA approval, you need to be sure to “dot every i and cross every t.” You’ll have many forms to complete, and they must all be carefully and correctly filled out. A common mistake for some medical startups involves nothing more than one minor oversight or questionable answer, which can delay the process. When that happens, you may need to resubmit for FDA approval and begin the process all over again. So, it’s best to avoid any errors or missteps the first time around.
3. Provide Accurate and Measurable Data
Clinical trials must be well-documented and should support any claims you make about the product. By providing supportive data, you’ll be in a better position to convince the FDA “powers that be” that your medical device offers many more advantages versus associated risks. Just like new pharmaceuticals, the FDA wants support to show that the new device isn’t just “quackery,” but that it offers doctors and patients something of value—safely.
In addition, it’s important that you keep accurate records of all stages of medical device development, from preclinical testing through clinical trials. This provides the FDA review team with a comprehensive overview of the device and its results.
4. Maintain Manufacturing Best Practices
As a medical device startup, you might be tempted to manufacture products through a facility that is, whether domestic or international, not particularly reputable. While this offers financial benefits at first, it is likely to damage your FDA-approval potential down the road.
The FDA is known to inspect manufacturing facilities as part of its approval process. For example, the number of manufacturing facilities the FDA inspected has grown more than 65% in the last decade. So, it is important that your facility, or those you use, are always inspection-ready and that good manufacturing practice (GMP) and Current Good Manufacturing Practice (CGMP) regulations are in place to protect consumers from unsafe products.
5. Keep In Touch with the FDA
The FDA is ready and willing to help in the development of any new medical device, so keep the lines of communication open! They will answer your questions regarding product approval, FDA applications, potential issues, clinical trials, and more. By keeping in touch with the FDA, you can reduce the need for repeated medical device review cycles and potentially speed up your chances for approval. Be sure to document all conversations you have with the FDA to refer to later in the application process if necessary.
6. Revise Your Promotional Pitch
Many medical device startup companies are excited about their revolutionary new product—and they should be! However, that can scare the FDA. If a product is pitched as an “industry disruptor,” that means it will get much more attention, and approval could take that much longer. Instead, consider pitching your medical device to the FDA with a list of similarities to other products on the market. This will help put them at ease when it comes to obtaining regulatory approval.
7. Consider the FDA’s Breakthrough Devices Program
Understanding that time can be of the essence when lives are on the line, this program exists to expedite approval on medical devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The program maintains the usual guidelines, but offers companies a quicker path to approval. You can learn more about the FDA breakthough designation here.
Come to Market with an Expert on Your Side
No matter what stage of medical device development you’re in, or whether you’ve begun the FDA approval process, Diberin Solutions can help. Our goal is to make sure medical device startups entering the industry succeed. We help you reach your full potential by bringing in experienced experts to ensure the success of your new company. We’ve helped startups like BandGrip, HomeThrive, DosentRx, and others get off the ground, and we want to help you. Contact us today to learn more.
