There continues to be much discussion over the FDA’s 510(k) program, which has led to controversy and confusion over the direction of the program. In fact, we have posted many blogs devoted to this topic, so we thought it was time to create a whitepaper focusing on the topic.
The purpose of the whitepaper is to establish the current status of the 510(k) process with regard to clinical data requirements, and then to begin to define some considerations that should be given to conducting a well-controlled clinical study, if, indeed, clinical data is required.
We realize that running a clinical study could be a monstrous undertaking for a company who historically has not had to produce clinical data for their 510(k) submissions, and this white paper has only begun to touch the surface.
Take time to download and review the whitepaper, we hope it helps provide you with a plan if your 510(k) requires clinical data.
Please let us know what you think.