FDA Launches Pilot Program to “De-risk the Medical Device Valley of Death”
The CDRH Total Product Life Cycle Advisory Program Pilot aims to improve the FDA authorization process for medical devices.
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.
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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.
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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.