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

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 "least burdensome appropriate means" 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.

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.

[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2424 Introduced in House (IH)]

114th CONGRESS
  1st Session
                                H. R. 2424

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


_______________________________________________________________________


                    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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 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.''.
                                 <all>