We are planning to expand product line to add a new product with a significant design change . We already have a approved 510k for our current design. Is a Special 510(k) appropriate regulatory pathway ? Please advise.
It is unlikely that a special 510(k) will be appropriate. A special 510(k) is used when there is a minor change to a product and you perform verification to assure it still meets the original design inputs. If there is a significant design change, it is probably that you design inputs have also changed.
We are planning to expand product line to add a new product with a significant design change . We already have a approved 510k for our current design. Is a Special 510(k) appropriate regulatory pathway ? Please advise.
Joanne,
That is a smart way to look at it. I reviewed the design again, and its not a significant design change. The change is not impacting the design i/o and no additional validation is required in terms of biocompatibility/sterilization /packaging.
Thanks again for the input.
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