; and (II) in the case of establishing or recognizing a standard, comply with the requirements described in section 514 for establishing or recognizing, as applicable, a performance standard. (iv) A person submitting a notification under section 510(k) may rely on a standard or guidance document identified, established, or recognized by the Secretary in accordance with clause (iii) to resolve some or all of the differences that exist between a new device and its legally marketed predicate device to demonstrate substantial equivalence. ; and (3) in subparagraph (F) (as redesignated by paragraph (1)), by adding at the end the following: (iv) The reliance on standards or guidance documents to demonstrate substantial equivalence as described in subparagraph (B) shall be optional and have no effect on the establishment of substantial equivalence pursuant to subparagraph (A) where such option is not exercised. .