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What the Medical Device Manufacturers need to know about FDA’s UDI requirements?

All the medical device manufacturers that intend to place their devices in the US should label their devices considering the Unique Device Identifier (UDI) requirements. UDI is a unique numeric or alphanumeric code that facilitates the identification, traceability, and tracking of medical devices during their distribution and use.  Recently, the FDA has suggested forms and contents of…

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Software Precertification Program: An Innovative Approach to Expedite Patient Access for SaMD

The Software Precertification (Pre-Cert) Program is a pathway that comprises a regulatory model which is more visible than the current model to assess the safety and effectiveness, without inhibiting patient access, of software technologies which are being used as Medical Devices. The U.S. Food and Drug Administration (FDA) introduced Software Precertification program to address problems…

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