FDA issues safety communication alert for Hospira’s Symbiq Infusion System.
Getting into the mindset of an FDA investigator during an inspection is not necessarily easy.
Inquiries from FDA cannot be ignored. You must respond, especially if the agency contacts your establishment more than once.
With the goal of acting as a single agency, FDA’s OCP has several activities planned for this year.
FDA’s perspective on human factors and usability engineering has evolved.
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.