October deadline nears, but still no US accredited person scheme?
This article was originally published in Clinica
The US FDA is keeping very close to its chest details concerning its new scheme where "accredited persons" in the US could audit manufacturers of Class II and III devices (medium to high risk) to FDA requirements. Indeed, so little information has been made available that some doubt that any third parties will be audited by October 26, the date by which the process should be completed and manufacturers should be able to use this new system.
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