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Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews

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Good Regulatory Review Practices

A Proposed Document by the International Medical Device Regulators Forum (IMDRF) Good Regulatory Review Practices Working Group is provided below for public comment.

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

Consultation documents

Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Review

Please use the comments template to provide comments on the Proposed Document and send comments via e-mail: melissa.torres@fda.hhs.gov with the subject line 'IMDRF Consultation'.

Comments Template - Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Review