Sec. 2242. Applicability and inapplicability of regulation
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Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 351 et seq. ), as amended by section 2221(a), is further amended by adding at the end the following: Except as provided in subsection (b), health software shall not be subject to regulation under this Act. Subsection
(a)shall not apply with respect to a software product— of a type described in subparagraph
(F)of section 201(ss)(1); and that the Secretary determines poses a significant risk to patient safety. In making a determination under subparagraph
(B)of paragraph
(1)with respect to a product to which such paragraph applies, the Secretary shall consider the following: The likelihood and severity of patient harm if the product were to not perform as intended. The extent to which the product is intended to support the clinical judgment of a medical professional. Whether there is a reasonable opportunity for a medical professional to review the basis of the information or treatment recommendation provided by the product. The intended user and user environment, such as whether a medical professional will use a software product of a type described in subparagraph
(F)of section 201(ss)(1). The Secretary shall delegate primary jurisdiction for regulating a software product determined under subsection
(b)to be subject to regulation under this Act to the center at the Food and Drug Administration charged with regulating devices. The Secretary shall review existing regulations and guidance regarding the regulation of software under this Act. The Secretary may implement a new framework for the regulation of software and shall, as appropriate, modify such regulations and guidance or issue new regulations or guidance. Notwithstanding subchapter II of chapter 5 of title 5, United States Code, the Secretary may modify or issue regulations for the regulation of software under this Act by administrative order published in the Federal Register following the publication of a proposed order. The review of existing regulations and guidance under paragraph
(1)may include review of the following areas: Classification of software. Standards for development of software. Standards for validation and verification of software. Review of software. Modifications to software. Manufacturing of software. Quality systems for software. Labeling requirements for software. Postmarketing requirements for reporting of adverse events. Not later than 18 months after the date of enactment of this section, the Secretary shall consult with external stakeholders (including patients, industry, health care providers, academia, and government) to gather input before issuing regulations, an administrative order, and guidance under this subsection. Nothing in this section shall be construed as providing the Secretary with the authority to regulate under this Act any health software product of the type described in subparagraph
(F)of section 201(ss)(1) unless and until the Secretary has made a determination described in subsection (b)(1)(B) with respect to such product. .
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Sec. 2242
Applicability and inapplicability of regulation
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