Documentation proves compliance, including when it comes to acceptance activities.
Failure to investigate complaints is a major compliance failure.
The event will seek input to develop a framework that tackles regulatory science gaps in cybersecurity.
Although not as stringently controlled as medical devices, veterinary devices fall under FDA’s authority. And the agency is watching.
The agency clarifies some misconceptions about requirements.
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.
FDA has not approved the device for the procedure, called transvascular autonomic modulation.
Considering rump injections? Head to the donut shop instead.
Healthcare providers are being warned about an increased rate of adverse cardiac events, as the agency conducts additional analyses.