What is the objective of using the app in clinical trails? If you are trying to conduct a study using the app that you should follow the same practices as you would do for a medical device and get IDE to perform the clinical trials. Please provide additional information to be able to better answer the question.
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Loganathan Kumarasamy, MS RAC
Senior Consultant
Waukegan IL
United States
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Original Message:
Sent: 01-Apr-2020 17:36
From: Anonymous Member
Subject: Smart Phone App Approval/Validation
This message was posted by a user wishing to remain anonymous
Can a clinical trial be conducted on a smart phone app that is being developed to provide diagnostic results for patients prior to the app (software) being submitted to Health Canada (HC) or FDA for approval/validation?
Or will the app be required to be submitted to HC/FDA prior to being used/tested in a clinical trial?
Thank you for your feedback asap.