The agency is seeking stakeholder feedback on the guidance, which seeks to clearly outline its recommendations for premarket submission content when it comes to cybersecurity concerns.
Clinicians at dozens of Defense Department, Coast Guard and Veterans Affairs sites were unable to update medical records for hours this past Wednesday.
UCLA Biodesign executive director Dr. Jennifer McCaney shares insights on a recent research project with BCG examining the global regulatory landscape, and discusses what excites her about the industry's future.