FDA: Industry’s Failure To Follow Guidance Increases 510(k) Review Times
This article was originally published in The Gray Sheet
Executive SummaryThe top reason FDA sends two or more requests for information during 510(k) reviews is because firms failed to follow guidance or recognized standards, said Christy Foreman, acting director of FDA’s Office of Device Evaluation.
You may also be interested in...
Less-invasive technologies to treat benign prostatic hyperplasia are fast becoming viable alternatives to medication and surgery. Here's what one researcher in the area, Steven Raman, had to say about the new options.
Novartis’s first digital innovation hub in Asia is launched in India, where the Swiss company hopes to ally with partners to deliver digital solutions for patients at scale.