Today, the FDA issued draft guidance: Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices to provide clarity on how the agency evaluates medical devices that electronically connect and interact with…
Today the FDA released a draft guidance document, “Unique Device Identification: Convenience Kits – Draft Guidance for Industry and Food and Drug Administration Staff ”. This document is intended to outline…
On December 3, 2015, the FDA’s Center for Devices and Radiological Health (CDRH) issued a revised version of the guidance document, “eCopy Program for Medical Device Submissions,” that clarifies certain…
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