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Software as a Medical Device (SaMD): Clinical Evaluation

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Software as a Medical Device (SaMD)

A Proposed Document has been released by the International Medical Device Regulators Forum (IMDRF) Software as a Medical Device (SaMD) Working Group.

Thank you for your contribution aiming at the validation of the IMDRF document.

Consultation documents

Software as a Medical Device (SaMD): Clinical Evaluation

Please use the comments template to provide comments on the Proposed Document and email comments to Bakul.Patel@tda.hhs.gov.

Comments - Software as a Medical Device (SaMD): Clinical Evaluation