FACTS Act
Bill: H.R.4511 | Sponsor: Rep. Burgess, Michael C. (R-TX)
Policy area: Health

Summary:
FDA Advancing Collection of Transformative Science Act or the FACTS Act
This bill establishes that certain data and determinations from a request for emergency use authorization for a drug, biological product, or medical device may apply to later regulatory procedures for that product.
Specifically, data generated to support a request for emergency use authorization may constitute valid scientific evidence to be considered for various later submissions to the Food and Drug Administration (FDA), including a request for market approval.
Also, when granting emergency use authorization for a medical device, if the FDA determines that the device performs certain simple low-risk examinations or procedures, that determination shall apply to certain other regulatory submissions unless additional information contradicts that determination.

To amend the Federal Food, Drug, and Cosmetic Act to authorize the use 
 of emergency use authorization data and real world evidence gathered 
   during an emergency to support premarket applications for drugs, 
       biological products, and devices, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``FDA Advancing Collection of 
Transformative Science Act'' or the ``FACTS Act''.

SEC. 2. USING EMERGENCY USE AUTHORIZATION DATA AND REAL WORLD EVIDENCE 
              GATHERED DURING AN EMERGENCY TO SUPPORT PREMARKET 
              APPLICATIONS FOR DRUGS, BIOLOGICAL PRODUCTS, AND DEVICES.

    Section 564(k) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360bbb-3(k)) is amended--
            (1) by striking ``If a product'' and inserting the 
        following:
            ``(1) In general.--If a product''; and
            (2) by adding at the end the following:
            ``(2) Data relating to a drug, biological product, or 
        device generated during emergency use.--Emergency use-related 
        data submitted by a sponsor in an application for, or 
        submission relating to, the approval, licensure, or clearance 
        of a drug, biological product, or device may constitute valid 
        scientific evidence or otherwise satisfy the standard of 
        evidence for approval, licensure, or clearance of such drug, 
        biological product, or device, and shall be considered for 
        purposes of--
                    ``(A) reviewing submissions and approving, 
                licensing, or clearing such drug, biological product, 
                or device pursuant to, as applicable, sections 505, 
                510(k), 513(f), and 515 of this Act and section 351 of 
                the Public Health Service Act; and
                    ``(B) otherwise meeting the requirements of this 
                Act or section 351 of the Public Health Service Act.
            ``(3) Applicability of certain categorizations for 
        premarket device review.--In the case of a device receiving an 
        authorization under this section for which the Secretary has 
        determined, in accordance with subsection (m), that a 
        laboratory examination or procedure associated with such device 
        is deemed to be in the category of examinations and procedures 
        described in section 353(d)(3) of the Public Health Service 
        Act, such determination shall apply with regard to a submission 
        pursuant to section 510(k), 513(f), or 515 for such device, 
        unless the Secretary (taking into account any applicable 
        conditions specified pursuant to subsection (m)(2) of this 
        section) identifies new information not included in the request 
        for authorization that indicates that the criteria under 
        section 353(d)(3) of the Public Health Service Act are not met.
            ``(4) Rule of construction.--Nothing in this subsection 
        shall be construed as altering the review standards or 
        otherwise affecting the requirements under section 505, 510(k), 
        513(f), or 515 of this Act, or section 351 of the Public Health 
        Service Act for the approval, licensure, or clearance of a 
        drug, biological product, or device.
            ``(5) Emergency use-related data defined.--
                    ``(A) In general.--In this subsection, the term 
                `emergency use-related data' means--
                            ``(i) data that is used to support the 
                        issuance of an authorization under this section 
                        with respect to a drug, biological product, or 
                        device;
                            ``(ii) data generated during the period 
                        under which such authorization is in effect, 
                        with respect to such drug, biological product, 
                        or device; and
                            ``(iii) real world evidence relating to 
                        such drug, biological product, or device used 
                        pursuant to such authorization.
                    ``(B) Exclusion.--Such term does not include data 
                previously reviewed and determined to be inadequate or 
                insufficient to support such an authorization.''.
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