The agency wants to make sure that all patients receive information about the risks of the female contraception device prior to implantation.
Innovations are helping companies to maintain compliance while driving operational gains across their supply chain.
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.