EPRs for Device Specification Setting

FDA generally considers Essential Performance Requirements (EPRs) as being the performance attributes responsible for the clinical performance of the device at the point of use (dosing) and include the device’s performance attributes relating to the user interactions required to administer the dose however, there is a lack of agreement as to which attributes constitute an EPR for a given injectable device leaving llicence holders and regulatory reviewers with significant freedom to interpret EPR’s. MediPhorum’s EPR workstream aims to generate industry-wide consensus for the benefit of all.

No consensus

No consensus view on how to interpret and apply Essential Performance Requirements (EPR) guidance. Licence holders and regulatory reviewers have significant freedom to interpret EPR’s. Differences in approach can lead to additional regulatory requests that were previously not required for the same delivery device.

Standardize approach

  • Understand the reason for the differences in how companies apply EPRs
  • Develop a standard approach for the interpretating and classifying EPR’s along the lines of ICH Q9
  • Align on applying EPR’s during device development and manufacture (control strategy)
  • Determine an acceptable test plan or control strategy for each EPR

Benefits: Reduce resource commitment for submissions

EPRs for Device Specification Setting deliverables

DeliverableDateDetailsDownload

Combination product essential performance requirements (EPR’s) interpretation and control strategy development – A MediPhorum appraisal

14 April, 2024
2.46 MB
6 downloads

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