Medical Device Regulation and The De Novo Process

New medical devices and novel uses for them should be celebrated as our world moves to continuously innovate. The FDA has been a driving force in the medical device industry’s move to innovate faster and further. One of the ways in which novel devices are brought to market is called the De Novo submission.

Medical devices are generally required to go through pre-approvals prior to being marketed and sold in the U.S. Most devices go through what is called the Premarket Notification or more popularly the 510k process. The 510k is a submission in which the manufacturer compares their device to an already-on-the-market predicate device. The other method of preapproval is the much more rigorous Premarket Approval or PMA. Instead of comparing your device to another, you are required to show that your device is safe and effective usually through scientific testing.

There is yet another, somewhat underutilized approach. This approach is called the De Novo submission. This type of submission is generally carved out for novel devices and new indications for use. This submission is also meant for devices that likely would fall into a Class I or II for medical devices. This means that they are safe and effective with the application of general or special controls.

This pathway has an added bonus – once the De Novo submission is approved, that device then becomes the standard against which all other devices of that type are compared. The submission comes with a pretty hefty price attached as well. The standard user fee for a De Novo submission is $93,000 and for a small business is $22,000. Add to that figure, the testing, consulting or FDA lawyer fees involved with compiling the submission and you are looking at a huge amount of money.

Most medical device companies will need to balance the costs against the profits that they are likely to make in determining the best course of action. The De Novo process is a promising one and contains many benefits for medical device companies looking to set the bar in their segment of the industry.