FDA’s Jeff Shuren, MD, and Timothy Stenzel, MD, discussed the flaws of the antibody testing guidance in a recently published editorial in The New England Journal of Medicine.
FDA approved, cleared, or authorized a record high of 132 novel medical devices in 2020, surpassing the 40-year high set in 2017.
Many global regulatory requirements now include risk management, so medtech companies may need to revisit their quality system processes.
As digitalization increases all around us, computer programs have also been making their way into our healthcare system. Software product developers must comply with various regulatory requirements depending on the intended use of the products...
The OPRA Implant System has been on the market under a humanitarian device exemption since 2015 and is now fully approved by FDA for patients who have trouble with conventional socket prosthetics.
There have been 27 complaints about this device issue, 26 reports of serious injuries, and one death has been reported.
The Dublin-based company inherited the DiamondTemp Ablation (DTA) system when it acquired Epix Therapeutics for $316 million in 2019.