The FDA is accusing a medical devicemaker of neglecting to report five cases of radiation leakage from its products and other reporting violations, according to a 10-observation Form 483. Read More

The FDA is extending a comment period to June 3 for its proposal to redefine third-party servicing for medical devices. Read More

Stakeholders are encouraging the FDA to beef up its stance on cybersecurity, making suggestions provided in draft guidance mandatory rather than voluntary.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Health Canada has finalized its regulations on in vitro diagnostic labeling 18 years after issuing draft guidance.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