The agency created the new post within CDRH, effective January 1.
Understanding the GMP requirements of each component is critical to product and compliance success.
The serology test is the first of its kind to detect neutralizing antibodies from a recent or prior SARS-CoV-2 infection.
The Abbott ID NOW test may return false negative results.
The agency has altered its import screening to accelerate the availability of PPEs.
The agency recently released a guidance document that gives device manufacturers an optional pathway to make certain modifications to their device.
The company developed the device as an alternative to reusable duodenoscopes, enabling the use of a new and sterile product for each procedure.
The agency’s move is a win for early screening of a rare genetic disorder, which leads to progressive muscle deterioration.
CooperVision, Inc. and Pentax of America won the agency approvals, respectively.
URGENT/11 introduces risks to medical device and hospital networks, and could allow a remote attacker to take control of a medical device such as an anesthesia machine of insulin pump.