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.