FDA requires that manufactures establish and maintain procedures regarding labeling activities.
Although not as stringently controlled as medical devices, veterinary devices fall under FDA’s authority. And the agency is watching.
How the shifting supply chain landscape and regulatory requirements will impact your business.
The agency clarifies the UDI rule for labelers and accredited issuing agencies.
Are you UDI-ready? Get the facts to achieve compliance fast.
The unique device identification rule is far more than just a labeling rule.
Well-written and usable instructions are critical for all users.
Mandatory revalidation may not be mandatory when a material change occurs; however, such changes need to be appropriately evaluated. When in doubt, repeat packaging validation. Or, if you believe the scientific evidence/rationale is adequate, then write a robust rationale as to why repeating packaging validation is not required.
Labeling is a top mission-critical business systems in medical devices; label documentation not only drives patient safety, but without it, there can be no product, revenue or profit. So how can better engagement, frank disclosure and shared long-term goals help medical device companies marry the right labeling partner?
The QSR does not dictate how to execute a Receiving Inspection program; it only stipulates that purchased materials must be assessed for their suitability to be used in the manufacture of medical devices that are safe and effective in their intended use. It is up to the establishment to define their approach to RI.