So you’re an inventor who wants to develop a medical device and use the invention in practice. You know the FDA regulates medical devices, but that’s about as far as your knowledge takes you.
Or, maybe you’ve been designing a device, have some prototypes, and someone said you needed to submit a 510(k).
Submitting to the FDA doesn’t have to be a daunting obstruction; let’s address some key considerations before you get ready to even start compiling your submission documents.
Briefly stated, a “510(k)”, as we commonly refer to it, is a pre-market notification to the FDA that shows your device is as safe and effective as another device already on the market. As implied, you compile your documentation together before any clinical use, and then the FDA will (hopefully) “clear” your device for use. Once submitted, plan on waiting around three months before you have a clearance letter in hand, barring any significant issues (in contrast, a PMA will require costly and lengthy clinical trials before the FDA “approves” it).
One of the absolute first things to do when developing a medical device is to understand the regulatory designation of your invention. The pathway and strategy may not always be clear cut at the onset, but you should have a firm grasp if you even need to submit a 510(k), which will dictate what is required to do during the development process.
There are three risk-based classes (I, II, & III), which range in stringency of regulatory control. The FDA has also established a system of classification codes and product codes, so you should determine if/how your device fits into one of these.
Knowing if your device requires special controls, is 510(k) exempt, or is GMP exempt can save you time and money in the long run by planning accordingly.
One aspect of analyzing your regulatory strategy early is identifying a predicate device (the one you’re going to compare to in safety and effectiveness). By defining an anticipated predicate, you will have more guidance on your design inputs and outputs and how to verify/validate them. Ideally, you know what testing will be required, either through standards or what was done with your predicate selection.
You need to be able to show “substantial equivalence” (SE) to this predicate. By identifying early, you (help to) ensure you maintain SE to another device. You may ask, how do I create a truly innovative device if I am required to say I’m the same as another device? Truth be told, you don’t need to have a “me too” product to obtain FDA clearance. Simply stated, as long as your device has similar aspects to a predicate that can be tested, SE can be shown.
510(k) submissions can range in complexity, but for the most part, the sections in which you divide your content is fairly straightforward. An entire article could be written on this question, so this blog will give you the “Cliff Notes” version: