510k updates? Any news?
the FDA's clock 60 days review is achieved since 2 weeks, seems that they received probably a bunch of questions and application was put on hold. If no PR posted, it may indicate that they want to keep this topics under the radars and may have received more conplex questions that they thought.
in normal time, when companies received question they can answer easily, they used to publish a PR to claim that they will answer FDA's additional information request shortly.
what are you thoughs on this