Big Chemical Encyclopedia

Chemical substances, components, reactions, process design ...

Articles Figures Tables About

IDE-Exempted Investigations

Exempted investigations may be conducted where the studies pose negligible risk to [Pg.191]

While there is no FDA involvement in such investigations, ethical considerations and institutional regulations would generally dictate that informed consent and the approval of the local institutional review board be obtained. However, due to the negligible risks involved these are likely to be a formality and will not involve extensive review or scrutiny. [Pg.192]


See other pages where IDE-Exempted Investigations is mentioned: [Pg.191]   


SEARCH



Exemptions

IDE Investigations

© 2019 chempedia.info