To amend the Federal Food, Drug, and Cosmetic Act with respect to training and oversight in least burdensome appropriate means concept.

Bill: 114-hr-2424
Sponsor: full_name: Rep. Shimkus, John [R-IL-15]
Introduced: 2015-05-19
Policy area: Health
Subjects: Administrative law and regulatory procedures

Department of Health and Human Services

Drug safety, medical device, and laboratory regulation

Food and Drug Administration (FDA)

Government employee pay, benefits, personnel management

Government studies and investigations

Health technology, devices, supplies

Product safety and quality
Latest action: action_date: 2015-05-22
text: Referred to the Subcommittee on Health.

Summaries:
action_date: 2015-05-19
action_desc: Introduced in House
text: <p>This bill amends the Federal Food, Drug, and Cosmetic Act to require Food and Drug Administration (FDA) employees involved in reviewing premarket submissions of medical devices to receive training regarding the &quot;least burdensome appropriate means&quot; concept. (Currently, the FDA must consider evaluating medical devices by the least burdensome appropriate means that would have a reasonable likelihood of resulting in approval.) The ombudsman for the FDA unit responsible for the premarket review of devices must audit this training and include in the audit interviews with persons from industry regarding their experience in the device premarket review process.</p> When the FDA requests additional information about a medical device that is required to have premarket approval, it must consider the least burdensome appropriate means necessary for an applicant to demonstrate the safety and effectiveness of the device.

tv_txt: I 114th CONGRESS 1st Session H. R. 2424 IN THE HOUSE OF REPRESENTATIVES May 19, 2015 Mr. Shimkus introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Federal Food, Drug, and Cosmetic Act with respect to training and oversight in least burdensome appropriate means concept.

1. Training and oversight in least burdensome appropriate means concept (a) In general Section 513 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360c ) is amended by inserting after subsection (i) the following: (j) Training and oversight in least burdensome appropriate means concept (1) Training 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). (2) Guidance documents (A) Draft updated guidance 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 . (B) Meeting of stakeholders 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. (3) Ombudsman audit 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— (A) conduct, or have conducted, an audit of the training described in paragraph (1); and (B) include in such audit interviews with a representative sample of persons from industry regarding their experience in the device premarket review process. . (b) Additional information regarding premarket applications 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 follows: (5) (A) 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. (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) Nothing in this paragraph alters the standards for premarket approval of a device. .