; and (D) promulgate additional regulations required by such amendments made by this Act. (3) Applicability of regulations Notwithstanding the date on which guidance or regulations are issued under paragraph (2), no guidance or regulations issued pursuant to the amendments made by this Act shall take effect until the effective date of this Act, as described in paragraph (1), except as otherwise provided for transitional tests. (b) Application of authorities to In vitro clinical tests until and after effective date of this Act Except as provided in subsection (d), for any product or test that is an in vitro clinical test as defined in section 201(ss) of the Federal Food, Drug, and Cosmetic Act, as added by this Act, the following authorities shall apply: (1) Tests offered prior to enactment An in vitro clinical test that meets the criteria for a grandfathered test as set forth in section 587A(c)(2) of the Federal Food, Drug, and Cosmetic Act, as added by section 3, may continue to be offered for clinical use and shall be subject only to applicable provisions of section 353 of the Public Health Service Act and section 587A(a)(4) of the Federal Food, Drug, and Cosmetic Act, as added by section 3. (2) Tests offered on or after enactment but before implementation Before any product or test that is an in vitro clinical test as defined in section 201(ss) of the Federal Food, Drug, and Cosmetic Act, as added by this Act, is first offered, sold, or distributed after the date of enactment of this Act, but prior to 90 days before the effective date of this Act, such product or test shall be considered a transitional test as described under subsection (d) and comply with the applicable device provisions of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq.) and the Public Health Service Act ( 42 U.S.C. 201 et seq.). (3) Tests under review beginning on or after the date of enactment of this act but prior to implementation For any product or test that is an in vitro clinical test as defined in section 201(ss) of