Following protocols and maintaining compliance have been common themes.
The agency anticipates the program will result in a two-thirds reduction of the amount of device malfunction reports submitted by manufacturers.
A look at where tech developments are originating and what to expect.
Many considerations should not be overlooked.
Digital transformation, artificial intelligence and start-up technologies are some of the topics that will be discussed at the event in November.
In pursuit of the almighty dollar, this case involves the smuggling of lamb fat.
CDRH is urging the development of medical technologies and diagnostic tests that address pain, addiction and diversion.
The document aims to clear up how the agency looks at device functions that aren’t subject to premarket review of safety and effectiveness.
When applicable, the process provides novel products with a speedier route to market.
The agency has issued its list of the most common inspectional observations for FY 2017.