Hani,
Are you asking what mechanism (notification) to FDA is needed or are you asking a different question? Did you agree on a stability protocol with FDA that goes beyond 6 months?
Dar
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Darlene Rosario
Principal Consultant RA, Quality and Compliance
Velocity Consulting
Ventura CA
United States
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Original Message:
Sent: 04-22-2014 07:58
From: Hani Rauch
Subject: Shelf life extension of DES during clinical trials
All,
We are at the begining of clinical trails for drug eluting stent systems (DES). The preliminary shelf life was set at 6 months after discussion with the FDA. We manufactured additional systems from each lot in order to perform mechnical and analytical test and extend the shelf life. How can we determain the new shelf life, assuming the tests pass their accepatnce criteria?
Thank you,
Hani
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Hani Rauch
Medinol
Tel Aviv
Israel
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