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Non-In Vitro Diagnostic Device Regulatory Submission Table of Contents (nIVD ToC)

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Regulated Product Submission

A Proposed Document by the International Medical Device Regulators Forum (IMDRF) Regulated Product Submission Working Group is provided below for public comment.

Thank you for your contribution in reviewing and providing feedback for this document.

 

Consultation documents

Non-In Vitro Diagnostic Device Regulatory Submission Table of Contents (nIVD ToC)

Please use the comments template to provide comments on the Proposed Document and send comments to Patrick Axtell and Daniel Yoon via email: patrick.axtell@fda.hhs.gov  and daniel.yoon@hc-sc.gc.ca  with the subject line 'Public Consultation on nIVD Table of Contents Working draft’.

Comments Table Template - IMDRF N9 (nIVD ToC) RPS WG