Medical devices entering the US market must be cleared by the FDA in a process known as regulatory submission. As the health care industry has grown, FDA requirements have become more stringent, so it’s important to be aware of the time and effort required to ensure product quality and patient safety.
How long can an FDA regulatory submission take?
Statistics show that the average time it takes to obtain clearance before commercial distribution has increased since the 510(k) process started in 1976. On average, approximately two thirds of applications submitted are cleared within six months. Although the FDA set a goal to respond to all 510(k) submissions within 90 days, it is uncommon to receive clearance within that time frame due to the fact many times the submitter is asked to submit additional information (AI). Also, the FDA must be notified 90 days prior to marketing a device, and the review process can take anywhere from six months to four years. 510(k) (premarket notification) to FDA is required at least 90 days before marketing unless the device is exempt from 510(k) requirements.
FDA medical devices are classified into three classes: Class I, Class II, and Class III. The FDA has classified about 1,700 devices so far. The different classes stand for the following:
Class I: They are low-risk devices. There are about 780 such devices.
Class II: They are medium-moderate risk devices. There are about 800 such medical devices.
Class III: They are of high risk, generally life supporting and life-sustaining. There are about 120 of them and each requires pre-marketing approval.
Companies determine the class of a device based on other devices with the same use or technology by submitting a 513(g) request or using the FDA classification database. Class I and II devices normally need a 510(k). A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval (PMA).
Class III products require a Premarket Approval (PMA) application and are often categorized as life-sustaining devices, such as pacemakers or replacement heart valves.
The Difference Between Premarket Approval and 510(k) Clearance
Unless exempted from the requirement, all Class III devices must obtain Premarket Approval. Premarket Approval is a scientific documentation submitted to the FDA that demonstrates the safety and effectiveness of a Class III device. PMAs employ the most stringent regulatory standards to make sure the device’s reliability far outweighs any risk to patients.
A 510(k) is a premarket submission to the FDA that demonstrates the device to be marketed is substantially equivalent (SE) to a legally marketed device not subject to PMA.
FDA Submission & Registration
Once cleared, a device’s registration status is added to the 501(k) or PMA database. If a company decides to alter the design or intended use of a legally marketed device, they will have to go through the regulatory submission process again.
How much does FDA regulatory submission cost?
FDA fees change annually and today are over $10,000. It is also, generally, a good idea to contract an FDA/Regulatory expert to assist you with your submission, which can cost another $35,000 or more. This expert can work closely with your development team and project manager to assist in streamlining the process for quicker results.
However, keep in mind that the cost of the submission is only about one tenth of the real cost. Devices requiring PMA will need substantial scientific data accumulated via clinical trials, which can be costly.
If the FDA agrees with a manufacturer’s claim that a device is similar to an already cleared product, companies can avoid expensive clinical trials and put their device on a fast track to market. Submitting a 510(k) is easier with help from a team of efficient and knowledgeable project managers. A comprehensive quality management system and project plan are key to obtaining FDA clearance and reaping a greater ROI.
Via Biomedical can streamline the process with our engineering expertise, shorten the time it takes to bring a product to market, and minimize project costs. Companies around the world trust our dedicated team to manufacture their devices on time and within budget. As an ISO 13485 certified medical device manufacturer, we routinely work with reliable vendors we trust to ensure FDA compliance from sterilization to biodegradable testing.
Contact us to learn more.