Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear RAPS community,

We are are medical device startup and are in the process of developing our first device, an implantable medical device. We are aiming to start a FIH clinical trial next year and a question has come up in the team regarding how much stability data (if any) is required by the ethics committee and competent authorities prior to approving the trial.

For example, we plan to demonstrate a shelf life of 24 months (with intermediate time points of 3-, 6-, 9- and 12-months) and will start the stability study soon. By the time we submit our clinical dossier to the EC and CA would data up to the 3-month timepoint be sufficient to gain approval for the trial?  I understand this may vary from country to country, but is there a timepoint that is generally accepted by all? 

Thank you in advance for your help!!

I didn't respond initially since I work with drugs as opposed to devices, but since I didn't see anyone else respond I can share that in the drug world your proposal would be acceptable. As long as you submit adequate stability data in your initial IND (or device equivalent) to cover the length of your clinical trial you are fine. Note I have no idea if this same philosophy holds true in device world.

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Tom
Senior Director, Regulatory Affairs CMC
Chicago
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Original Message:
Sent: 01-May-2020 13:00
From: Anonymous Member
Subject: Stability Data Prior to Clinical Trials

This message was posted by a user wishing to remain anonymous

Dear RAPS community,

We are are medical device startup and are in the process of developing our first device, an implantable medical device. We are aiming to start a FIH clinical trial next year and a question has come up in the team regarding how much stability data (if any) is required by the ethics committee and competent authorities prior to approving the trial.

For example, we plan to demonstrate a shelf life of 24 months (with intermediate time points of 3-, 6-, 9- and 12-months) and will start the stability study soon. By the time we submit our clinical dossier to the EC and CA would data up to the 3-month timepoint be sufficient to gain approval for the trial?  I understand this may vary from country to country, but is there a timepoint that is generally accepted by all?

Thank you in advance for your help!!