It is Dr. D’s humble opinion that the execution of an effective internal audit program falls into the basic blocking and tackling bucket.
Money should never be a higher priority than safety and efficacy.
You can’t just validate processes—you have to monitor them, too.
Problems have persisted with the Essure System. What’s FDA’s next move?
FDA simply won’t tolerate extreme claims outside a product’s cleared or approved use.
If you’re using software in the product development process, it better be validated.
Having a robust device master record is not optional.
If you climb into FDA’s sandbox, be prepared to play by the rules.
A twist on the classic holiday song, complete with FDA condemnation.
FDA takes control of non-conforming product seriously.