Protocol, report or SOP for threshold analysis?

#1
For GENERIC products involving drug-device combinations, threshold analysis is recommended as outlined in the following guidances;

Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry

Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications Guidance for Industry and FDA Staff

this has reference to HE75: 2009-Human factors engineering—Design of medical devices,

quite a few reference and articles are available online, but not a single example format or template around it.

Hence above request if you could share any reference or example for same of threshold analysis
 
Last edited by a moderator:

Top Bottom