DUAL SUBMISSION FOR CERTAIN DEVICES.

SEC. 3301. DUAL SUBMISSION FOR CERTAIN DEVICES. Section 513 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c) is amended by adding at the end the following:“(k) For a device authorized for emergency use under section 564 for which, in accordance with section 564(m), the Secretary has deemed a laboratory examination or procedure associated with such device to be in the category of examinations and procedures described in section 353(d)(3) of the Public Health Service Act, the sponsor of such device may, when submitting a request for classification under section 513(f)(2), submit a single submission containing—“(1) the information needed for such a request; and “(2) sufficient information to enable the Secretary to determine whether such laboratory examination or procedure satisfies the criteria to be categorized under section 353(d)(3) of the Public Health Service Act.” .