The bill has received bipartisan support for removing barriers and accelerating innovation in medical devices, drugs and biologics.
There are several steps you can take to ensure your mHealth app is keeping patient health data safe and secure.
As wearable technology within the medical device industry heats up, FDA makes some clarifications on which products fall into general wellness and low-risk categories.
Unique factors are involved when designing adhesives for the face and other fragile parts of the skin.
Susan Alpert, principal of SFA Consulting, explains the role of clinical evidence for combination products and the complexities at play.
Finding ways to better manage inventory, provide security and product integrity, and maintain continuous improvement are among the goals of logistics professionals.
The comprehensive approach to human factors considers how a product operates alone, interoperability in larger settings, and data management.
The creation of the Office of Combination Products more than a decade ago may have been a big step forward, but frustrations surrounding policy-making and coordination between CDRH, CDER and CBER remain.