Documentation proves compliance, including when it comes to acceptance activities.
Failure to investigate complaints is a major compliance failure.
Although not as stringently controlled as medical devices, veterinary devices fall under FDA’s authority. And the agency is watching.
When device modifications could affect safety and effectiveness, a premarket notification submission is required.
The design history file establishes the baseline for the design and development of a device.
Considering rump injections? Head to the donut shop instead.
Don’t overlook this critical practice.
You don’t need to tell FDA all the gory details.
This week’s offenders are charged with smuggling and unlawful use of silicone, injecting it straight into the buttocks.
Denying the agency to inspect your facility is a violation.