Few things motivate FDA faster than a significant number of adverse events, especially deaths.
Inspections are inevitable. If you receive 483s, follow these tips to quickly and adequately respond to the agency.
Perhaps the organizational soul searching should begin after receiving one Form 483.
The agency has entered the next phase of requests: Postmarket surveillance studies.
Device establishments should be able to read and comprehend 21 CFR Part 807.
It is in the best interest of an offending establishment to be timely and complete in responding to Form 483 observations.
The agency is focused on ensuring device establishments accelerate compliance with the eMDR process.
It’s never too late to work towards compliance, and quick.
Comply all the time, not just when FDA announces an inspection.
If complex medical devices such as endoscopes and duodenoscopes cannot be reprocessed safely, why is this practice permitted?