In the case of devices that are composed of substances or combinations of substances that are intended to be introduced into the human body and that are absorbed by or locally dispersed in the human body, detailed information, including test design, complete test or study protocols, methods of data analysis, and data summaries and test conclusions, regarding studies in relation to:
I gcás feistí atá comhdhéanta de shubstaintí nó de theaglamaí substaintí a beartaíodh lena dtabhairt isteach i gcorp an duine agus a ionsúitear nó a scaiptear go logánta i gcorp an duine, faisnéis mhionsonraithe lena n-áirítear dearadh na tástála, an tástáil iomlán nó prótacail an staidéir, na modhanna anailíse sonraí, agus achoimrí sonraí agus conclúidí tástála, maidir le staidéir a bhaineann leis an méid seo a leanas: