To amend the Federal Food, Drug, and Cosmetic Act with respect to the recognition of standards.

This bill amends the Federal Food, Drug, and Cosmetic Act to allow a person to request that the Food and Drug Administration (FDA) recognize all or part of a performance standard established by a nationally or internationally recognized standard organization as a standard to which a medical device may conform in order to meet an FDA requirement. When a request to recognize a standard is received, the FDA must determine whether to recognize all, part, or none of the standard and publish the rationale for that determination. (Currently, the FDA recognizes certain performance standards, but it is not required to respond to requests or publish rationales for recognizing standards.)

The FDA must: (1) publish the rationale for recognizing only part of a standard, (2) periodically train employees who review premarket submissions for medical devices on the concept and use of recognized standards for purposes of meeting requirements, and (3) publish its principles for recognizing standards.

[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2425 Introduced in House (IH)]

114th CONGRESS
  1st Session
                                H. R. 2425

 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
                       recognition of standards.


_______________________________________________________________________


                    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 the 
                       recognition of standards.

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

SECTION 1. RECOGNITION OF STANDARDS.

    Section 514(c) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360d(c)) is amended--
            (1) in paragraph (1), by inserting after subparagraph (B) 
        the following new subparagraphs:
                    ``(C)(i) Any person may submit a request for 
                recognition under subparagraph (A) of all or part of an 
                appropriate standard established by a nationally or 
                internationally recognized standard organization.
                    ``(ii) Not later than 60 days after the Secretary 
                receives such a request, the Secretary shall--
                            ``(I) make a determination to recognize 
                        all, part, or none of the standard that is the 
                        subject of the request; and
                            ``(II) issue to the person who submitted 
                        such request a response in writing that states 
                        the Secretary's rationale for that 
                        determination, including the scientific, 
                        technical, regulatory, or other basis for such 
                        determination;
                    ``(iii) The Secretary make a response issued under 
                clause (ii)(II) publicly available, in such manner as 
                the Secretary determines appropriate.
                    ``(iv) The Secretary shall take such actions as may 
                be necessary to implement all or part of a standard 
                recognized under subclause (I), in accordance with 
                subparagraph (A). 
                    ``(D) The Secretary shall make publicly available, 
                in such manner as the Secretary determines appropriate, 
                the rationale for recognition under subparagraph (A) of 
                part of a standard, including the scientific, 
                technical, regulatory, or other basis for such 
                recognition.''; and
            (2) by adding at the end the following new paragraphs:
            ``(4) Training on use of standards.--The Secretary shall 
        provide to all employees of the Food and Drug Administration 
        who review premarket submissions for devices periodic training 
        on the concept and use of recognized standards for purposes of 
        meeting a premarket submission requirement or other applicable 
        requirement under this Act, including standards relevant to an 
        employee's area of device review.
            ``(5) Guidance.--
                    ``(A) Draft guidance.--The Secretary shall publish 
                guidance identifying the principles for recognizing 
                standards under this section. In publishing such 
                guidance, the Secretary shall consider the experience 
                with, and reliance on, a standard by other Federal 
                regulatory authorities and the device industry, and 
                whether recognition of a standard will promote 
                harmonization among regulatory authorities in the 
                regulation of devices.
                    ``(B) Timing.--The Secretary shall publish--
                            ``(i) draft guidance under subparagraph (A) 
                        not later than 12 months after the date of the 
                        enactment of the 21st Century Cures Act; and
                            ``(ii) final guidance not later than 12 
                        months of the close of the public comment 
                        period for the draft guidance under clause 
                        (i).''.
                                 <all>