Consultation closed

Playbook for Medical Device Regulatory Reliance Programs

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Good Regulatory Review Practices

IMDRF Affiliate Members and members of Regional Harmonization Initiatives are especially encouraged to comment on the Proposed Document contents, especially as they relate to the development and use of reliance programs in their own jurisdiction. 

Consultation documents

Playbook for Medical Device Regulatory Reliance Programs

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

 

Please use the comments template to provide comments on the Proposed Document and send comments to Ken Cavanaugh and Lai Peng Low via email: kenneth.cavanaugh@fda.hhs.gov and low_lai_peng@hsa.gov.sg with the subject line 'Public Consultation on reliance playbook’. 

Comments Template for Reliance Playbook (N89)