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.
Know when to submit a 510(k) with these 4 Questions
What is a 510(k)?
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).
Do I even need to submit?
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.
What is my predicate device(s)?
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.
So, what do I need to submit?
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:
- Indications for Use – one of the first steps in the development process is to define your clinical need and what you’re treating. Note that your device’s indications must fall under your selected predicate device’s intended use.
- Substantial Equivalence – the heart of the submission—you must show SE through design verification activities such as testing.
- Performance Testing – this can include any and all bench, animal, and clinical testing as outlined in your design plan.
- Biocompatibility – depending on the material and how your device contacts the user/patient, you may be required to demonstrate biocompatibility.
- Electromagnetic Compatibility – if your device includes electronics, you may need to show EM compatibility and overall electrical safety, usually referencing IEC 60601.
- Software – if your device includes software, you will have to verify those inputs and outputs as well.
- Proposed Labeling – this includes instructions for use, surgical technique guides, and user manuals in addition to the labels on the device and packaging.
- Sterilization & Shelf Life – you will need to provide your sterilization method and specifications. If you are providing a device sterile to the user, you will need to include this validation in your submission; if not, you only need to submit your protocol. The same is true for shelf life activities.