Consultation closed

Essential Principles and Content of Predetermined Change Control Plans

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Closing date
Working group
Software as a Medical Device

A Proposed Document by the International Medical Device Regulators Forum (IMDRF):

Essential Principles and Content of Predetermined Change Control Plans

Please provide your feedback through the IMDRF Consultation Hub on Citizen Space by following this link. 

The response questionnaire will also enable respondents with more than 10 change requests to download a word document for upload once completed. This template is also attached below.

 

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

The consultation period for this document is now closed. Please contact IMDRFSaMDWG@fda.hhs.gov if you have additional questions or feedback.

 

Consultation documents

Essential Principles and Content of Predetermined Change Control Plans
Feedback Template (for use with more than 10 changes)