Hello!!
What do you think about the subject. Is there any sense to submit the 510k to third party?? It is claimed that it could speed up the handling of application. Does anyone have any experience on this subject???
We have class II MEdical Device

Yes, it speeds up the process. We have class II medical device as well and we submitted our 510(k) through third party. It was easy and quicker to answer questions.

Yes, it speeds up the process. We have class II medical device as well and we submitted our 510(k) through third party. It was easy and quicker to answer questions.FDA promises 90 days. I thought that FDA still did a cursory review after the third party review. How much quicker was the process with the third party review and how much was the additional cost?

The process was carried out within 2 months. We were able to answer some questions rather quickly as well. It was our first attempt. It did cost some money, but it was much less than paying a regulatory consultant to do the submission for us.