It can be incredibly frustrating when you have submitted your 510(k) and haven’t heard any word back in months. However, this is actually to be expected since the FDA receive huge amounts of Pre-Market Applications on a daily basis. There isn’t much you can do to make them work faster, however, there are a few things you can do yourself to ensure that your submission doesn’t experience any hiccups along the way. Here are some of the best tips to help you to avoid any 510(k) clearance delays:
Submit to a Third Party Review Company
The best action you can take to ensure that your submission is reviewed as fast as possible, is to submit it to a third person review company such as fdathirdpartyreview. A company such as this one has been approved by the FDA as an Accredited Persons, who are able to review 510(k)’s and carry out the initial review processing of the submission.
Once they have reviewed the submission, the third party company then forwards their findings directly to the FDA on your behalf. The FDA are required by law to finalise the FDA 510k clearance submission and provide the results of your 510(k) within a time frame of 30 days. This provides people with faster results, which means they are able to market their devices quicker than if they were to send their proposal to FDA from the very beginning.
Avoid Making Mistakes in your Application
To avoid any hiccups or delays with regards to your actual 510(k) submission and the reviewing process, it is best to make sure the information you provide is free from any errors. Make sure that your application includes all of the relevant information requested by the FDA, including the predicated device. This device must be correct in terms of similar properties so that you can accurately compare and prove that your device is both safe and effective.
Attend a Pre-Submission Meeting
Many people may benefit from attending a Pre-Submission meeting which can be a useful event for those who would like to learn more about the submission process. These meetings offer relevant guidance and advice with regards to your 510(k) submission and are able to answer any questions or concerns you may have in connection with the process. This is a great opportunity to lessen any possible delays with your application as you will be able to gather a clearer insight into the premarket application process, allowing you to complete your 510(k) as smoothly as possible.