Are you a manufacturer looking to sell your medical devices in the United States? If so, you need to be familiar with the FDA 510(k) clearance process. Under the requirements of the Food, Drug, and Cosmetic Act, device manufacturers must provide at least 90 days' notice to the FDA of their intent to market a medical device. This is known as premarket notification, also referred to as PMN or 510(k).
The 510(k) is a submission document that manufacturers submit to the FDA to demonstrate that their device is as safe and effective as legally marketed devices, meaning it is substantially equivalent (FD&C Act section 513(i)(1)(A)), and does not require premarket approval. The 510(k) clearance process is one of two ways medical device manufacturers can obtain approval from the Food and Drug Administration. It is important to note that the device approval under this section is not a true "approval" in the legal sense. The 510(k) clearance simply grants a company permission to sell their product.
On average, the FDA approves approximately 2,825 devices (95% CI, 2,733-2,917 devices) through the 510(k) process each year, while only 31 devices (95% CI, 24-38 devices) are approved through the more rigorous PMA (premarket approval) process. So, what is the difference between 510(k) and PMA?
The 510(k) clearance is FDA authorization to market a moderate-risk medical device, whereas higher-risk and novel products require PMA (premarket approval). Generally, 510(k) applicants can expect to receive a decision on acceptance for review within 15 calendar days, a substantial review decision within 60 days, and a final decision within 90 days. However, the actual time for 510(k) submission often exceeds the 90-day period.
Now, you may be wondering about the cost of FDA 510(k) clearance. Most of our FDA 510(k) clients typically spend tens of thousands of dollars preparing and reviewing their products or devices before the actual submission process. The specific cost depends on the complexity and intricacy of the device. But here's the good news: your 510(k) clearance does not expire and remains valid until you make changes to the intended use, instructions for use, or technological characteristics of your device.
Do you need a Quality Management System (QMS) for your 510(k)?
As mentioned earlier, a QMS is a prerequisite for submitting a 510(k), as both your medical device production and FDA inspection readiness depend on it. However, it is not the only document required for preparing a 510(k) submission. Your 510(k) submission package will also include various additional requirements.
If your device requires FDA 510(k) submission, our team at Spica can provide you with professional and experienced support. We understand the intricacies of the process and will guide you through every step, ensuring a smooth and successful submission. Don't let the FDA clearance process become a hurdle – let us help you bring your innovative medical device to the US market.