Many small and large companies ask this question: how long is this process going to take? Unfortunately, there is no concrete answer. One of the biggest stalls in generating revenue is FDA approval. If you haven’t prepared for this approval process until later in the game, then you’re likely going to be waiting even longer.
The FDA Medical Device Approval Process
The process can vary and can take anywhere between a week or six months. Depending on the steps you’ve already taken, this process could be on the longer side. Bringing a new medical device to the market is not a quick feat. You need to register, submit a 510(k) application, and possibly submit a Premarket Approval (PMA) as well. This is why it is always smarter to start preparing for the FDA submission as soon as you can.
There are three pathways to marketable approval, and they are 510(k) submissions, PMA, or self-registration. But to evaluate the speed at which your device will be approved, you need to determine if your device is a class I, II, or III device.
Differences in Medical Device Classifications
Medical devices are categorized by their associated risk. Class I being the lowest, whereas class III having the highest risk. Most Class I devices are exempt from 510(k) clearance. These devices can be as simple as electric toothbrushes or oxygen masks.
Class II devices are what most new medical devices are categorized as. Approximately 43% of medical device applications fall within the Class II categorization. These devices pose a moderate risk and typically require a 510(k) application. Of the Class II devices, the most common ones on the market are contact lenses, catheters, and syringes. The FDA must respond to 510(k) applications within 60 days of receiving them. This application shows that the manufacturers have demonstrated the safety of the device.
Class III medical devices are typically the new innovative and invasive devices that are breaking headlines. Since these tend to have a higher risk to health and safety, they are classified as Class III. Defibrillators, prostheses, implants, and pacemakers are all considered class III medical devices. These products typically require more intensive preparation, and will likely require a PMA pathway. The PMA is the process of scientific review and requires more extensive evidence than other types of registration. The average PMA application can take up to 240 days to be approved, which is a bit longer than 510(k).
How To Speed Up The FDA approval Process
Unfortunately, there is no tried-and-true method of speeding up the process. If your device falls under Class I, self-registration may be the quickest. The biggest takeaway, however, would be to get started early on, the longer you wait, the longer it could take.
The way your submission is written may also have an impact on its approval. Providing substantial evidence of your safe and innovative device will likely make the process more manageable, rather than doing the bare minimum.