Stakeholders are encouraging the FDA to beef up its stance on cybersecurity, making suggestions provided in draft guidance mandatory rather than voluntary. Read More

Health Canada has finalized its regulations on in vitro diagnostic labeling 18 years after issuing draft guidance. 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 FDA is looking to ban electrical stimulation devices used to prevent self-injury and aggressive behavior. Read More

In a rare move, the FDA has revoked the mammography quality standards act certificate from a California radiology facility. Read More

The FDA has added five new modules to its CDRH Learn online platform covering the Unique Device Identification program. Read More