Blogs #Regulations
Who is responsible for registering a trial?
An appropriate representative of the trial’s primary Sponsor. The Responsible Registrant is responsible for ensuring that the trial is properly registered. The primary Sponsor may or may not be the primary funder.
How does FDA classify medical devices?
In accordance with the Federal Food, Drug, and Cosmetic Act, FDA places all medical devices into one of three regulatory classes based on the level of control necessary to ensure safety and effectiveness of the device