Congress Passes New FDA Medical Devices User Fee Amendments (MDUFA V) Deal
The new deal provides the FDA a minimum of $1.78 billion in user fees from 2023 to 2027.
Smart Inhalers May Enable Better Management of Respiratory Disorders
Inhalers and sensors that offer digital monitoring are beginning to gain FDA approval, and could solve usage issues of traditional products.
Already a member? Log in here
Medical Device User Fees Agreement Finally Nearing the Finish Line
Though it took longer than expected, the medtech industry and FDA have finally agreed on medical device user fees for the next five years.
Already a member? Log in here
Many Medical Device Companies Are Not Ready for Cyberattacks
According to a recent survey of product security experts, despite many saying their companies are ready for hacks, data show otherwise.
FDA Lays Out New Guidelines for Medical Device Cybersecurity
With cyberattacks becoming increasingly common, the FDA has issued long-awaited draft guidance to help device makers deal with the threat.
Already a member? Log in here