IMDrf Finalizes SaMD Document

The IMDRF Management Committee approved the final N12 document, “Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations”. IMDRF publishes their documents at the link provided. This document should be posted in the near future. FDA participates actively in the International Medical Device Regulators Forum (IMDRF) which is seeking to harmonize international regulation.

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