Sec. 3058. LEAST BURDENSOME DEVICE REVIEW
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## SEC. 3058 LEAST BURDENSOME DEVICE REVIEW ###
(a)In general Section 513 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c) is amended by adding at the end the following: > > ### “(j) Training and Oversight of Least Burdensome Requirements > > > #### “(1) > > The Secretary shall— > > > ##### “(A) > > ensure that each employee of the Food and Drug Administration who is involved in the review of premarket submissions, including supervisors, receives training regarding the meaning and implementation of the least burdensome requirements under subsections (a)(3)(D) and (i)(1)(D) of this section and section 515(c)(5); and > > > ##### “(B) > > periodically assess the implementation of the least burdensome requirements, including the employee training under subparagraph (A), to ensure that the least burdensome requirements are fully and consistently applied. > > > #### “(2) > > Not later than 18 months after the date of enactment of the 21st Century Cures Act, the ombudsman for any organizational unit of the Food and Drug Administration responsible for the premarket review of devices shall— > > > ##### “(A) > > conduct an audit of the training described in paragraph (1)(A), including the effectiveness of such training in implementing the least burdensome requirements; > > > ##### “(B) > > include in such audit interviews of persons who are representatives of the device industry regarding their experiences in the device premarket review process, including with respect to the application of least burdensome concepts to premarket review and decisionmaking; > > > ##### “(C) > > include in such audit a list of the measurement tools the Secretary uses to assess the implementation of the least burdensome requirements, including under paragraph (1)(B) and section 517A(a)(3), and may also provide feedback on the effectiveness of such tools in the implementation of the least burdensome requirements; > > > ##### “(D) > > summarize the findings of such audit in a final audit report; and > > > ##### “(E) > > within 30 calendar days of completion of such final audit report, make such final audit report available— > > > ###### “(i) > > to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives; and > > > ###### “(ii) > > on the Internet website of the Food and Drug Administration.” > . ###
(b)Premarket Applications Section 515(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(c)) is amended by adding at the end the following: > > #### “(5) > > > #####
(A)> > In requesting additional information with respect to an application under this section, the Secretary shall consider the least burdensome appropriate means necessary to demonstrate a reasonable assurance of device safety and effectiveness. > > > ##### “(B) > > For purposes of subparagraph (A), the term ‘necessary’ means the minimum required information that would support a determination by the Secretary that an application provides a reasonable assurance of the safety and effectiveness of the device. > > > ##### “(C) > > For purposes of this paragraph, the Secretary shall consider the role of postmarket information in determining the least burdensome means of demonstrating a reasonable assurance of device safety and effectiveness. > > > ##### “(D) > > Nothing in this paragraph alters the standards for premarket approval of a device.” > . ###
(c)Rationale for Significant Decisions Regarding Devices Section 517A(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360g-1(a)) is amended by adding at the end the following: > > #### “(3) Application of least burdensome requirements > > The substantive summary required under this subsection shall include a brief statement regarding how the least burdensome requirements were considered and applied consistent with section 513(i)(1)(D), section 513(a)(3)(D), and section 515(c)(5), as applicable.” > .
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