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Stakeholders are encouraging the FDA to beef up its stance on cybersecurity, making suggestions provided in draft guidance mandatory rather than voluntary. Read More
Companies that develop laboratory-developed tests should begin to incorporate design controls and establish a quality system ahead of the expected finalization of FDA guidance this year, experts advise. Read More
The Senate HELP Committee unanimously advanced to the full Senate a bill that would give the FDA additional tools to review and ensure the safety of medical devices, such as duodenoscopes. Read More