When it comes to adverse event reporting, the FDA does not grant exemptions.
Many considerations should not be overlooked.
After one year into the transition period, it is clear that manufacturers are not where they need to be in meeting the compliance deadline.
How simple labeling changes can drive big results for medical device manufacturers.
In pursuit of the almighty dollar, this case involves the smuggling of lamb fat.
Think outside of the box and approach your QMS with passion and creativity.
This is the second alert the agency has issued in less than one year.
CDRH is urging the development of medical technologies and diagnostic tests that address pain, addiction and diversion.
Here’s a hint: Compliance with new regulation in Europe is a high priority.
When FDA says stop, they mean stop!