NSE devices may not be subject to recall
This article was originally published in The Gray Sheet
FDA will evaluate the need for reprocessors to recall distributed devices deemed "not substantially equivalent" on a case-by-case basis, according to a CDRH release. AdvaMed is concerned that the agency's language does not obligate reprocessors to notify end users that NSE devices are no longer legally allowed to be marketed. The trade group is requesting FDA to reconsider its position on contacting end users directly...
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