A 510(k) Submission must be cleared by the FDA to allow you to legally market your device within the United States. However, building a successful Premarket Application is more difficult than it looks. Here are the top 5 most common mistakes when submitting a 510(k) and how to avoid them:
- Failure to Understand the History of your Product
Since you will need a predicate device to compare your new device with as a part of your 510(k) submission, failure to know and understand the history of your specific product in the U.S can be a huge mistake. You must be aware of how your device fits into the history timeline of previously approved and similar devices to your own.
- 510(k) Misunderstandings
Another common mistake made by applicants is being unaware of the main goal of the 510(k) reviewing process. Your device must be eligible in order to qualify for FDA approval. Make sure to carry out significant research before submitting your 510(k) and ensure that your device is eligible for a Premarket Application to avoid wasting your time.
- Choosing an Incorrect Predicate Device
You will need to choose the right comparison device for your product. The predicate device is a previously cleared device that has been approved by the FDA and that shares similar qualities to your own device. Examples include materials, design, indications for use, packaging and sterility etc. According to www.mddionline.com, failing to choose the right predicate device will result in the FDA asking you for “additional data or clarification, which slows the review process.”
- Submitting to the FDA instead of an Accredited Persons
Technically, this is not a mistake in the typical sense. However, choosing to send your FDA 510k clearance submission directly to the FDA instead of fdathirdpartyreview, will result in an extended time period between submission and clearance. A third party review program will be able to provide faster feedback. This means that you will be able to have your device on the market much faster whilst still obtaining top quality services from a FDA approved company.
- Simple Errors and Inconsistencies
Many people overlook easy errors and mistakes within their 510(k) submission. There is a lot to get through in the application process that you may find yourself unable to notice if you have included misinformation or perhaps forgot to include some important details. To avoid making any mistakes with your submission, it is a good idea to have someone proofread your submission.