Regulatory News In Brief
This article was originally published in The Gray Sheet
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Assurance Cases Are Slowing Down Infusion Pump Submissions, Branch Chief Says
The need for infusion pump manufacturers to prepare safety cases is slowing down 510(k) submissions for the products, said Richard Chapman, the head of CDRH's General Hospital Devices review branch.
Assurance Cases Are Slowing Down Infusion Pump Submissions, Branch Chief Says
The need for infusion pump manufacturers to prepare safety cases is slowing down 510(k) submissions for the products, said Richard Chapman, the head of CDRH's General Hospital Devices review branch.
Regulatory News In Brief
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