Are you a manufacturer looking to sell your medical devices inthe United States? If so, you need to be familiar with the FDA510(k) clearance process. Under the requirements of the Food, Drug,and Cosmetic Act, device manufacturers must provide at least 90days' notice to the FDA of their intent to market a medical device.This is known as premarket notification, also referred to as PMN or510(k).
The 510(k) is a submission document that manufacturers submit tothe FDA to demonstrate that their device is as safe and effectiveas legally marketed devices, meaning it is substantially equivalent(FD&C Act section 513(i)(1)(A)), and does not require premarketapproval. The 510(k) clearance process is one of two ways medicaldevice manufacturers can obtain approval from the Food and DrugAdministration. It is important to note that the device approvalunder this section is not a true "approval" in the legal sense. The510(k) clearance simply grants a company permission to sell theirproduct.
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 throughthe more rigorous PMA (premarket approval) process. So, what is thedifference between 510(k) and PMA?
The 510(k) clearance is FDA authorization to market amoderate-risk medical device, whereas higher-risk and novelproducts require PMA (premarket approval). Generally, 510(k)applicants can expect to receive a decision on acceptance forreview within 15 calendar days, a substantial review decisionwithin 60 days, and a final decision within 90 days. However, theactual time for 510(k) submission often exceeds the 90-dayperiod.
Now, you may be wondering about the cost of FDA 510(k)clearance. Most of our FDA 510(k) clients typically spend tens ofthousands of dollars preparing and reviewing their products ordevices before the actual submission process. The specific costdepends on the complexity and intricacy of the device. But here'sthe good news: your 510(k) clearance does not expire and remainsvalid until you make changes to the intended use, instructions foruse, or technological characteristics of your device.
Do you need a Quality Management System (QMS) for your510(k)?
As mentioned earlier, a QMS is a prerequisite for submitting a510(k), as both your medical device production and FDA inspectionreadiness depend on it. However, it is not the only documentrequired for preparing a 510(k) submission. Your 510(k) submissionpackage will also include various additional requirements.
If your device requires FDA 510(k) submission, our team at Spicacan provide you with professional and experienced support. Weunderstand the intricacies of the process and will guide youthrough every step, ensuring a smooth and successful submission.Don't let the FDA clearance process become a hurdle – let us helpyou bring your innovative medical device to the US market.
