Hello Anon,
Accelerated aging for the shelf life of packaging and device (keep in mind those are often two distinct testing) are generally accepted by regulatory agencies. This is indeed using the standard ASTM F1980 as Lee mentioned, but there are other derivations of accelerated aging including calculations at different temperatures using the Arrhenius equation - because some materials can not withstand very high temperatures, i.e. 50 degree C. Though as the regulatory agencies accept accelerated aging as part of a submission, there needs to be the commitment, e.g. having a written protocol and hopefully already started, with the real time aging. I experienced a couple bad situations in the past where they committed to the real-time aging and either was not finished or not done to protocol which was identified at a later date during an inspection. Let's just say the inspection went from ok to much worse. So real time aging is necessary and must be performed according to the protocol and expected shelf life or expiration date.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Principal Strategy Consultant
NAMSA
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Original Message:
Sent: 27-Apr-2024 11:08
From: Lee Leichter
Subject: Stability and Shelf-life using accelerated - FDA ICH or Arrhenius?
Hi Anon,
ICH is for medicinal products, not medical devices. FDA has accepted accelerated aging for both packaging (package integrity) and functional testing at the time of submission. The recognized standard referenced most often is ASTM F1980 − 21, which uses an Arrhenius type calculation for accelerated aging. However, it, like all other schemes, requires real time aging to be ongoing to confirm the time established by the accelerated aging.
You should be OK with accelerated data at the time of submission. If you are concerned, this is one question that could be easily addressed in a Q-sub meeting.
Lee
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Lee Leichter RAC
President
P/L Biomedical
Fort Denaud FL
United States
Original Message:
Sent: 26-Apr-2024 06:02
From: Anonymous Member
Subject: Stability and Shelf-life using accelerated - FDA ICH or Arrhenius?
This message was posted by a user wishing to remain anonymous
Hello Forum!
We are currently having discussion regarding initiation of stability studies and the whether the application of a shelf-life to general medical devices (wound care products, hemostats, gels) can be done based on accelerated aging data and calculated using the ICH guidance calculation or the Arrhenius. The devices are not using complex materials and are not combination devices which I know FDA would only accept real-time data.
The devices are for sale in Europe, US and Internationally. Therefore, to streamline the company would like to use a one fits all kind of approach (mainly Arrhenius as shorter/ quicker) for submissions.
Does/ will the FDA accept a shelf-life application based on data from accelerated aging stabilities using the Arrhenius calculation? or does it have to be ICH / real time?