‘‘(A) classify the device pursuant to section 
513; and 
‘‘(B) determine whether, absent reciprocal 
marketing approval, the device would need to be 
cleared pursuant to section 510(k) or approved 
pursuant to section 515 to be lawfully marketed 
under this Act. 
‘‘(g) CONGRESSIONAL DISAPPROVAL OF FDA OR-
DERS.— 
‘‘(1) IN GENERAL.—A decision of the Secretary 
to decline to grant reciprocal marketing approval 
under this section shall not take effect if a joint res-
olution of disapproval of the decision is enacted. 
‘‘(2) PROCEDURE.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), the procedures described in sub-
sections (b) through (g) of section 802 of title 
5, United States Code, shall apply to the con-
sideration of a joint resolution under this sub-
section. 
‘‘(B) TERMS.—For purposes of this sub-
section— 
‘‘(i) 
the 
reference 
to 
‘section 
801(a)(1)’ in section 802(b)(2)(A) of title 
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5, United States Code, shall be considered 
to refer to subsection (c)(2); and 
‘‘(ii) 
the 
reference 
to 
‘section 
801(a)(1)(A)’ in section 802(e)(2) of title 
5, United States Code, shall be considered 
to refer to subsection (c)(2). 
‘‘(3) 
EFFECT
OF
CONGRESSIONAL
DIS-
APPROVAL.—Reciprocal marketing approval under 
this section with respect to the applicable covered 
product shall take effect upon enactment of a joint 
resolution of disapproval under this subsection. 
‘‘(h) APPLICABILITY OF RELEVANT PROVISIONS.— 
The provisions of this Act shall apply with respect to a 
covered product for which reciprocal marketing approval 
is in effect to the same extent and in the same manner 
as such provisions apply with respect to a product for 
which approval or clearance of an application or pre-
market notification under section 505(c), 510(k), or 515 
of this Act or section 351(a) of the Public Health Service 
Act, as applicable, is in effect. 
‘‘(i) FEES FOR REQUEST.—For purposes of imposing 
fees under chapter VII, a request for reciprocal marketing 
approval under this section shall be treated as an applica-
tion or premarket notification for approval or clearance 
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under section 505(c), 510(k), or 515 of this Act or section 
351(a) of the Public Health Service Act, as applicable. 
‘‘(j) OUTREACH.—The Secretary shall conduct an 
outreach campaign to encourage the sponsors of covered 
products that are potentially eligible for reciprocal mar-
keting approval to request such approval. 
‘‘(k) DEFINITIONS.—In this section— 
‘‘(1) the term ‘coronavirus’ means SARS–CoV– 
2, COVID-19, or another coronavirus with epidemic 
potential; and 
‘‘(2) the term ‘covered product’ means a drug, 
biological product, or device that is intended to treat 
or prevent the coronavirus or another disease with 
epidemic potential.’’. 
Æ 
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