14/15 June 2022
In our News dated 25 September 2017, we announced the finalisation of an FDA guideline for the qualification of development tools for medical devices. Development has played a major role for the FDA not only in the pharmaceutical sector, but also for medical devices, for a long time now.
Since this topic is very important for the FDA, a website is dedicated to it where a webinar as well as the corresponding slides can be viewed. The minutes of the webinar are also available on this webpage. Just recently, a webinar, its slides as well as the protocol with regard to special applications for clinical trials with medical devices (IDE) and for the "approval" of medical devices (510k, PMA) has been added and can be viewed on the FDA website.