Simplifying Global Compliance
Investigator Did Not Document Adverse Effects, FDA Says
Devices & Diagnostics Letter
The investigator in a device clinical trial failed to document adverse device effects, did
not obtain informed consent from all participants and deviated from the investigational plan without approval, according to an FDA warning letter.
To View This Article:
Subscribe To Devices & Diagnostics Letter
Copyright ©2018. All Rights Reserved.
Design, CMS, Hosting & Web Development :: ePublishing