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Real Time Stability

Discussion in 'Medical Devices (21 CFR Part 820)' started by QA Bee, Jan 14, 2016.

  1. QA Bee

    QA Bee Member

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    We are a "Class 1 Exempt" IVD Medical Device company both ISO 9001 and 21 CFR Part 820 certified.

    Do our products need "Real Time Stability" or "Accelerated Stability" should be good enough?
    Also, Do each and every product that's design need stability or just a product family? Because most of our products are just Antibodies, Reagents and Chromogen families.
    Thank you.
     
  2. Vintage Goose

    Vintage Goose Active Member

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    Hi, even though you are not submitting a 510(k), there is the expectation in 21CFR820 and the IVD Directive that validation and verification will be performed. Both CLSI guidelines and ISO 23640 (Evaluation of stability of IVD reagents) require real time studies. ISO 23640 says:

    "Data from accelerated stability studies and/or experience gained with IVD reagents that can reasonably be expected to be comparable with regard to their stability characteristics may be taken into account for establishing initial expiry dating. Experience with similar reagents and the risk associated with the use of the device should be used to establish the basis for initial expiry dating. If, at the time of placing an IVD reagent onto the market, stability claims are based on such previous data, the claim shall be verified with real time study data." (my emphasis)

    Also, per ISO 23640, this should be on three batches.

    Chris
     
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  3. QA Bee

    QA Bee Member

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    Thanks Chris for your input. I really appreciate it.
    I have hard time convincing Management that its required for even Class 1:(
     
  4. Ronen E

    Ronen E Well-Known Member

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    Hi,

    The term "class I exempt" indicates to me that the relevant context is US FDA regulation. Classification under the EC IVD directive works differently and thus it's impossible to determine from your post how your devices would be classified under the IVD directive (or if it's relevant to you at all), and what would be the consequent requirements. Therefore my response is limited to the US FDA regulation aspect.

    Second, organizations can't be "21 CFR part 820 certified". The closest, you have had an FDA inspection which was successfully closed out. If that's the case, and you products needed real-time stability studies, FDA staff would have looked into that and told you about it.

    Normally, the term "class I exempt" relates to a 510(k) exemption, but some product codes are also "GMP exempt" (exempt from part 820). From your mention of part 820 I gather that your devices don't fall under such codes. Had it been the case, your company wasn't even on FDA's routine inspection schedule, and you would have been inspected only "for cause" (which I hope and assume you weren't).

    Please also note that even where part 820 does apply, most class I devices are exempt from Design Control (820.30) under which design verification and validation (including product life) come. Subpart 820.30 states the few class I categories that aren't exempt. If 820.30 doesn't apply, I can't think of another regulatory basis that would oblige you to validate expiry through real-time (or even accelerated) ageing.

    I'm not an expert on IVD MD, but the general practice for MD which require stability studies is to run pre-market accelerated ageing, then to start running real-time ageing in parallel with (or slightly prior to) commencing distribution. This way the real-time stability controls are always one step ahead of distributed devices and action can be taken if any issues arise. This "one step" should preferably be long enough to allow a timely worst-case recall.

    To your last question, you might be able to bundle devices from "a family" together in a stability study. A definite answer must consider the scientific details. If you have a solid scientific rationale (preferably backed by past experience) why the would behave the same, it might be accepted.

    All the above is written from a strict regulatory perspective. I did not opine on the quality benefits of validating stability through either real-time or accelerated ageing. I assume your management is aware of such benefits however they must also consider the business implications.

    Cheers,
    Ronen.
     

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