Not granting the agency full access for the purpose of conducting an inspection is going to end badly for the offending establishment. The staunch reality of failing to grant FDA access for an inspection is free admission to regulatory purgatory until as such time access is granted and a re-inspection performed.
Device establishments that manage to navigate the often treacherous waters associated with our heavily regulated industry manage to do so through an effective CAPA system. CAPAs should always be viewed as proactive tools needed to drive quality and regulatory compliance in support of an effective QMS.
Determining device classification is an extremely important task. So if you have some concerns over the selection of the correct classification, remember that it’s acceptable to ask FDA for guidance.
It is football season, so I employ a football metaphor to kick off this week’s guidance: The control of nonconforming product should be considered a basic element needed to support an effective Quality Management System, not unlike the need to get the basic fundamentals right in football, blocking and tackling.
There are so many issues associated with the failure to establish procedures for acceptance activities, the failure to collect documented evidence of acceptance activities, DHR issues, and DMR issues… So establish, establish, establish, and establish.
The only takeaway the doctor is going to leave with the readers for this edition of DG is eloquent in its simplicity; “always do the right thing!”
What happens when the contract manufacturer a device establishment selects for manufacturing support runs afoul of FDA?
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.
Significant changes made to the design or processing of finished medical devices, that are safe and effective in their intended use, require the review and subsequent approval of FDA. This includes changes in the indication for use.
It is incumbent upon your organizations to ensure that the classifications of devices entered into commerce are properly classified and the applicable QMS requirements understood and implemented. Class I or Class II exempt has nothing to do with the actual QSR requirements and pertains only to the regulatory pathway.
