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Competence and Training Requirements for Regulatory Authority Assessors of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews

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

This consultation closes on Tuesday, 26 May 2020.

Working Group Chair: Melissa Torres, USA

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

Consultation documents

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