Sec. 2223. Training and oversight in least burdensome appropriate means concept
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Section 513 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360c ) is amended by adding at the end the following: Each employee of the Food and Drug Administration who is involved in the review of premarket submissions under section 515 or section 510(k), including supervisors, shall receive training regarding the meaning and implementation of the least burdensome appropriate means concept in the context of the use of that term in subsections (a)(3)(D) and (i)(1)(D) of this section and in section 515(c)(5).
Not later than 12 months after the date of enactment of the 21st Century Cures Act , the Secretary shall issue a draft guidance document updating the October 4, 2002, guidance document entitled The Least Burdensome Provision of the FDA Modernization Act of 1997: Concept and Principles; Final Guidance for FDA and Industry . In developing such draft guidance document, the Secretary shall convene a meeting of stakeholders to ensure a full record to support the publication of such document.
Not later than 18 months after the date of issuance of final version of the draft guidance under paragraph (2), the ombudsman for the organizational unit of the Food and Drug Administration responsible for the premarket review of devices shall— conduct, or have conducted, an audit of the training described in paragraph (1); and include in such audit interviews with a representative sample of persons from industry regarding their experience in the device premarket review process. .
Subsection
(c)of section 515 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360e ) is amended by adding at the end the following: Whenever the Secretary requests additional information from an applicant regarding an application under paragraph (1), the Secretary shall consider the least burdensome appropriate means necessary to demonstrate device safety and effectiveness, and request information accordingly. 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. Nothing in this paragraph alters the standards for premarket approval of a device. .
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Sec. 2223
Training and oversight in least burdensome appropriate means concept
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