Citation[edit | edit source]

21st Century Cures Act, Pub. L. No. 114–255 (Dec. 13, 2016).

Overview[edit | edit source]

On December 13, 2016, the 21st Century Cures Act (Cures Act) was signed into law. Section 3060(a) of the Act, titled "Clarifying Medical Software Regulation," amended the FD&C Act to add section 520(o), which describes software functions that are excluded from the definition of the term device in section 201(h). In addition, section 520(o)(2), reproduced below, describes the regulation and assessment of a software product with multiple functions, including at least one device function and at least one software function that is not a device.

Section 520(o)(2) of the FD&C Act (21 U.S.C. §360j(o)(2)) says:

In the case of a product with multiple functions that contains—(A) at least one software function that meets the criteria under paragraph (1) or that otherwise does not meet the definition of device under section 201(h); and (B) at least one function that does not meet the criteria under paragraph (1) and that otherwise meets the definition of a device under section 201(h), the Secretary shall not regulate the software function of such product described in subparagraph (A) as a device. Notwithstanding the preceding sentence, when assessing the safety and effectiveness of the device function or functions of such product described in subparagraph (B), the Secretary may assess the impact that the software function or functions described in subparagraph (A) have on such device function or functions.

Proponents said that it would streamline the drug and device approval process and bring treatments to market faster. Opponents said that it would allow drugs and devices to be approved on weaker evidence, bypassing randomized, controlled trials, and bring more dangerous or ineffective treatments to market.

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