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Release of products from trials

Discussion in 'Qualification & Validation (21 CFR Part 11)' started by PaMark, Apr 19, 2016.

  1. PaMark

    PaMark New Member

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    My company wants to replace a cotton material used in their current Class II device with a synthetic fiber material that is used in all other predicate devices. We know we have to submit a Special 510K to be cleared to use this new material. We have run several small-scale trials, scrapping all the outputs, and confirmed that the new material is fully functional and meets all design inputs related to the use of this material, and it appears to successfully run under all process conditions previously validated for the original material.
    In order to establish appropriate statistical evidence for design verification/validation and 510K submission, the company needs to run a larger trial at a significant cost. All finished goods are being held from distribution. My question is whether these finished goods can eventually be released and distributed if all appropriate controls are recorded and consistent with the DMR that comes out of the design process? And there is no expiration date for these single-use, non-sterile products.
     
  2. QAengineer13

    QAengineer13 Member

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    In my previous job where I was employed with OEM manufacturer of Wound care dressing and health care products (Drape, surgical tapes etc), I have been in a same situation where we have negotiated as part of the contract with the OEM's about the Trial run and the cost involved, but from your post it feels like you have already crossed that juncture, and its not clear as to what are the DMR items and Design control elements related to Material selection process, design input, output , V &V were recorded and documented before and during the run. The real problem is that if you were to write a V &V plan and report after the fact the run was completed, the Production run output is not valid. So My 2'c would be to look into other avenues (For research use only purposes , commercial purposes ) than a medial device application as the Tractability is Key and the design control record for Qualification and verification records has to be clearly documented and successful before launch.

    Probably it would be useful to understand what records, plan documents were signed before the batch run to see the case where you can still use the material or not ?. Hope I understood your situation properly from your post, if not please explain further.
     

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