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Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Device Regulatory Reviews

A Proposed Document on Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Device Regulatory Reviews has been released by the International Medical Device Regulators Forum (IMDRF) Good Regulatory Review Practices Working Group.

This consultation closes on Monday, 19 April 2021.

Working Group Chair: Melissa Torres

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 email comments to Melissa.Torres@fda.hhs.gov.