For some reason, the thought of submitting a 510(k) to the FDA gives many inventors and manufacturers sweaty palms, butterflies in their stomachs and an unnerving sense of dread. This is mainly due to the fact that they believe the process to be a lot more difficult than it actually is. We are going to simplify the process for you so that you can submit your 510(k) without having any daunting thoughts or worries to hold you back.
What is a 510(k)?
This is a type of premarket notification that is submitted to the FDA to determine whether or not the said device is eligible to be on the market. The FDA will decide, after a series of tests, if your device is both safe and effective as an existing device that has already been approved. The process is usually quite lengthy, which is why it is advised that you instead forward your FDA 510k clearance submission to an Accredited Person such as http://www.fdathirdpartyreview.com. Taking this advised route will ensure that your submission will be completed in shorter time period than if you were to go directly to the FDA.
What Should your Include in your 510(k) Submission?
There are various aspects of your device that must be submitted in your 510(k). These include:
- Indications for Use – You must define the purpose of your device. What is the devices clinical need? What are you treating? Etc.
- Substantial Equivalence – You design verification activities must showcase the substantial equivalence of your device, in other words, what existing device does it mimic in terms of safety and effectiveness etc.
- Performance Testing – Include relevant testing that was carried out (animal, clinical etc.)
- Software – Include any software inputs and outputs.
- Biocompatibility – How does your device react with the user?
- Electromagnetic Compatibility – Include any electronic information that is relevant to your device.
- Proposed Labelling – Include instructions and any relevant user manuals and guides etc.
- Sterilization & Shelf Life – Provide sterilization method, as well as specifications. You may need to include validation if your device is sterile. Otherwise, submitting your protocol should be sufficient. Don’t forget to include the shelf life of the product.
Depending on your specific device, you may need to include additional information in your 510(k). If you are I doubt, refer to the official FDA website to ensure you have included everything you need in your final submission and good luck!