How long does it take to get a medical device approved?
One of the most common questions someone has while developing a new medical device is “how long will it take to get my device approved?” The answer is very simple: it depends! Timeline depends on the device and the regulatory pathway, there are some common rules to go by that will help give you a good idea for your product. First, you need to completely describe the intended use of your device. This is the first step to figuring out if your device will require regulatory clearance before you can market it. For help, check out our blog on determining if your product is a medical device.
Pathways and costs
In general, the timeline and cost of getting your medical device increase with the risk and complexity of the device. In the case where your device can be classified as a Class 1 device (or in some special Class 2 device cases), you can market your device without any premarket notification. This does not mean you do not have to follow the medical device regulations - see our article on if your Class I device needs a quality system. For specific device codes, you can check FDA’s database to see if they are exempt from premarket notification.
If you are required to submit a premarket notification to FDA, there are several pathways for devices - 510(k), Premarket Approval (PMA), or de Novo. All of these pathways require the submission of documentation to the FDA, as well as paying a user fee (from about $13,000 for 510(k) to almost $400,000 for a PMA). If you are a small startup, you are in luck; you do get discounts to incentivise innovation! While the FDA will give you a decision about your premarket notification application within about 90 days, it takes a significant amount of development time to be ready to submit your device. FDA typically has additional questions after the 90 day period, so it’s the safest approach to assume a 120 day timeframe to get your final decision.
The most important factor in determining how long it will take to get your medical device approved is how long it takes you to complete the development of your device. It’s important to remember that only finished devices can be cleared, and that only testing performed on finished devices is acceptable for submitting to the FDA. Several studies suggest that it takes anywhere from 3 to 7 years to complete the design of a medical device and bring it to market with FDA clearance.
See how Nemedio can help speed your medical device development timeline along!