The center is working to address the delays in meeting review timelines for product submissions.
GI Genius is based on machine learning and helps clinicians detect lesions in real time during a colonoscopy.
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.