FDA categorizes shelf life and aging studies as design
validation, instead of, or
maybe in addition to, design verification. Also noteworthy is that the gold standard (my opinion) AAMI Design Control Requirements and Industry Practice course (typically done with FDA participation) traditionally categorized shelf life and aging studies the same way. Various authors of design control publications also agree with this. Moreover, ISO/TC 210 for the context of ISO 13485 (a standard with which FDA is "converging" in the near future) and sterile products also seems to agree in its categorization of shelf life studies as "validation".
These longstanding precedents seem to make sense because users need the product to survive the labeled shelf life. Moreover, shelf life and aging studies must involve production units or their equivalents in order to be meaningful and valid representations of the final marketed product.
Along the same lines, FDA's design control guidance document reminds us that design validation is a cumulative summation of all efforts to assure that the design will conform with user needs and intended use(s),
given expected variations in components, materials, manufacturing processes, and the use environment. There may be no example that more clearly epitomizes these principles than shelf life and aging studies. I think this is probably an underlying principle in FDA Warning Letters demanding that shelf life / aging studies be done under the controls of design validation.
Given these precedents, reasoning, and scientific principles, I wonder how we could ever possibly or reasonably expect FDA to change its mind on this so that FDA would instead accept the questionable notion that shelf life and aging studies are actually just design verification that don't need to be subject to the controls of design validation? I think it's best that we keep with the longstanding categorization of shelf life and aging studies as design
validation until a more defensible regulatory and scientific rebuttal can be offered.
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 17-Oct-2022 19:28
From: Dan O'Leary
Subject: Shelf Life and Design Control
There are a few things going on here, so let me break then apart.
In one part you say shelf life an in another part you say aging. For most devices they are the same. However, for some device, often IVDs, there is an aging component on the shelf with the packaging unopened and an aging component after the package is opened. I infer you are interested in shelf-life component only.
Shelf-life is a design input which produces a design output. Checking that the design out matches the design input is design verification, but typically not design validation. See Ed Bill's cogent comments.
Shelf-life is often split into two segments – accelerated and real time. You should have successfully completed the accelerated segment before design transfer. The real-time segment will still be running waiting for completion.
Both accelerated and real-time shelf-life testing are part of design verification.
You bring up 510(k) submission. This is a different process with a different timeline. Generally, the Reviewer will expect the data from the accelerated test and a description of the real-time test.
While you can complete design transfer in stages before you have a 510(k) clearance, you cannot legally ship the finished device before receiving the clearance. When there are long lead times, some design transfer may occur before receiving the clearance.
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Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 13-Oct-2022 14:40
From: Anonymous Member
Subject: Shelf Life and Design Control
This message was posted by a user wishing to remain anonymous
Hi,
If shelf life studies (accelerated aging for 1 year shelf life) are included as a Design Control deliverable for V&V to be included in a 510k, then what phase should real time aging be included as a deliverable? Or can design control/design transfer be closed out without any real time aging studies?
Thanks in advance for your input.