When it comes to adverse event reporting, the FDA does not grant exemptions.
When FDA says stop, they mean stop!
All equipment must be qualified and calibrated for its intended use.
Can your company prove its device has been manufactured in accordance with its DMR?
The duodenoscope manufacturers didn’t comply with requirements to conduct postmarket surveillance studies assessing reprocessing effectiveness.
Training is not a nice-to-have; it’s a fundamental requirement.
You must respond within 15 days, and you must show FDA how your establishment will be brought back to compliance.
The agency found several violations during an inspection related to its investigation of inaccurate blood lead test results.
Failing to report serious patient injuries will win you a warning letter.
The doctor struggles to understand how the observation extracted from the warning letter referenced in this week’s guidance managed to rise to the level of a Form 483 Observation.