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.
New virtual and in-person workshops will bring together FDA and industry experts and stakeholders on a variety of key issues.
This second article in the 4-part series looks at the use of software in medical devices in non-clinical settings, particularly the home environment. It addresses software’s role in the home healthcare trend, explains the software-related risks that arise from home-use products, and discusses what manufacturers can do to make these products safer.
How do you find meaningful signals in the middle of masses of noise, correctly interpret those signals and apply them for a useful purpose?