Kai Harrekilde-Petersen This could vary based on the product type, but my experience with Hearing Aids is a "no".
The actual devices that we put on subjects won't go through the accelerated aging, but other samples will go through the test.
For us, the Accelerated Stress Test gives an indication of how robust the design is, but is not a test of the product efficacy over aging as such. It's more a production (ie: operator skill) and lifetime robustness measure.

Michael Lehmicke When you ask about pre-clinical validation are you specifically referring to biocompatibility/animal model testing? In general this can be run separately (often in parallel) with accelerated aging. This assumes that you have appropriately characterized the device and therefor can measure any potential degradation by other methods (e.g. mechanical testing or chemical characterization).

Rommel Garcia Let us say, you are developing a non-class I device. But you are right in a sense that it depends on the Classification. A Tip... look at it in point of view on a Gate-Phase system...

Rommel Garcia Hi Mike,
Pre-Clinical Validation is usually performed on either animal or bench. Biocompatibility is part of validation test performed at the Clinical Stage. The Clinical Stage will require Accelerated Aging because there are other characterization that is associated with it. Clinical is at V&V Phase.

Sri Vishnubhotla I would say no as long as the post accelerated samples have specific performance criteria that can be verified...validation ensures user needs are met...

Rommel Garcia Any takers?

Rommel Garcia A quick and dirty answer is: In a Phase Gate process, the Pre-Clinical evaluation is performed at the Feasibility Phase. At the Feasibility Phase, an application for IDE is submitted first and approved before any Clinical studies can be performed. At the Feasibility Phase, there are no provisions for verification of packaging, bio-compatibility and others (except for initial studies) because the final device for Development Phase is not finished yet. Accelerated Aging (AA) requires you to have information about a lot about the conditioning, sterilization, labeling and others including Arrhenius calculations which you will not have in the Feasibility Phase. Another is Pre-Clinical Evaluation concentrates on how the device itself is used clinically. The intent is to give the Design Team an idea or solidification of the Human Factor or Usability, Design Intent and other claims that can be documented.

Its a feasibilities study prior to validation

Rommel Garcia Zul, if you are talking about Clinical Evaluation, it is after Feasibility Phase. Pre-Clinical Studies is at the Feasibility Phase. Clinical Evaluation or Device Validation is performed at the V&V Phase in which you are validating the finished Medical Device. The build for such device is after Verification. Clinical some takes a long time most specially if you are doing it on Combo Devices...

Guido Vezzu Dear Garcia, not sure I understand the Phase Gate process your company is following. However, even if you are developing a device for use in an IDE study design control needs to be applied. V&V is performed prior to the clinical phase. The devices used for design verification and validation purposes must be representative and equivalent to the finally released product with the claimed shelf-life. Very often it is possible to argue, why a non-aged medical device is representative for non-clinical testing on the bench or in an animal model. There may however be cases where this is not obvious at all or where for other considerations you still want to perform the sterilization, transportation testing and accelerated aging. That said, the decision should be documented in the protocol and if the argument is solid you will be fine.

Rommel Garcia Hi Mr Vezzu, Phase Gate System is widely used in the industry as a form of installing more visibility of the project from the management perspective. If you will view the waterfall from FDA on Design Control, it follows the same principle. What is not emphasize in that waterfall are the Phases that differentiate each stage to another that is why Phase Gate is developed to show and clearly define the stages. Each Phase has defined deliverable and those deliverable are the items that are reviewed during Design Review. All of those requirements are embedded in the Design Development Plan ( 21 CFR 820.30 Section b or Section 7.3.2 of ISO 13485). The nomenclature for the Phases can vary from from company to company depending on how their QMS and QSR. IDE is a mechanism for the company to perform Clinical Trials ( http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm279103.pdf ) which is normally in the Feasibility Phase prior to Development and V&V.

Rommel Garcia Mr Vezzu, To continue with the answer to your comment... You can look up the PPT that I have attached in my profile for you to be able to understand what I meant about Phases in the development of Medical Device. Going back to Feasibility Phase, it is where the actual solidification of Design Input occurs. At this point, initial prototypes are built to be used to get an objective evidence that the design will work, hence, Pre-Clinical study using bench, animal (or cadaver) can be used just to determine "Does it work or not". So therefore, AA or Accelerated Aging is not needed. Now, if all the verification is done and the device is ready for prime time, Clinical Study Validation is performed, that is where all of the AA is needed because you will have to contend with everything from the performance of the SBS to the Sterility, to that actual efficacy of the device.
I hope this answers it.

Guido Vezzu Hello Mr. Rommel, thank you for the additional material and informations. I understand now where you are coming from. Kind Regards, Guido

Rommel Garcia Great conversation...