[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1527 Introduced in House (IH)]







105th CONGRESS
  1st Session
                                H. R. 1527

 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
        classification of and performance standards for devices.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 1, 1997

 Mr. Upton (for himself, Ms. Eshoo, Mr. Greenwood, Mr. Towns, and Mr. 
Hall of Texas) introduced the following bill; which was referred to the 
                         Committee on Commerce

_______________________________________________________________________

                                 A BILL


 
 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
        classification of and performance standards for devices.

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

SECTION 1. SHORT TITLE; REFERENCES TO FEDERAL FOOD, DRUG, AND COSMETIC 
              ACT.

    (a) Short Title.--This Act may be cited as the ``Medical Device 
Regulatory Flexibility Act''.
    (b) References to Federal Food, Drug, and Cosmetic Act.--Except as 
otherwise expressly provided, whenever in this Act an amendment or 
repeal is expressed in terms of an amendment to, or repeal of, a 
section or other provision, the reference shall be considered to be 
made to a section or other provision of the Federal Food, Drug, and 
Cosmetic Act.

SEC. 2. INITIAL CLASSIFICATION.

    Section 513(f) (21 U.S.C. 360c(f)) is amended--
            (1) in paragraph (1) in the last sentence, by striking 
        ``paragraph (2)'' and inserting ``paragraph (2) or (3)'';
            (2) by redesignating paragraphs (2) and (3) as paragraphs 
        (3) and (4), respectively; and
            (3) by inserting after paragraph (1) the following new 
        paragraph:
    ``(2)(A) Any person who submits a report under section 510(k) for a 
type of device that has not been previously classified and which is 
classified into class III under paragraph (1), may request that the 
Secretary classify the device in class I or II, under criteria set 
forth in subparagraphs (A) through (B) of subsection (a)(1), within 30 
days of receiving written notice of the classification. Such request 
shall describe the device and provide the reasons supporting such 
person's recommended classification for the device based on specified 
classification criteria.
    ``(B) Not later than 60 days after the date of the request for 
classification under criteria set forth in subparagraphs (A) through 
(B) of subsection (a)(1), the Secretary shall by order classify the 
device and notify in writing the person who submitted such request of 
the classification. Such classification shall be the initial 
classification of the device for purposes of paragraph (1). Any device 
which is classified into class III under this subparagraph shall be 
deemed adulterated within the meaning of section 501(f)(1)(B) until 
approved under section 515 or exempted from such approval under section 
520(g).''.

SEC. 3. DEVICE STANDARDS.

    (a) Alternative Procedure.--Section 514 (21 U.S.C. 360d) is amended 
by adding at the end thereof the following:

                   ``Listing of Recognized Standards

    ``(c)(1) The Secretary may, through publication in the Federal 
Register, issue notices to identify and list nationally and 
internationally recognized standards which--
            ``(A) shall be the special controls to which persons my 
        certify compliance for purposes of the special controls 
        required by section 513(a)(1)(B);
            ``(B) the Secretary may for purposes of device 
        classification use in establishing the equivalence of one 
        device to another; and
            ``(C) may be used by the Secretary in considering an 
        application for premarket approval of a class III device.
    ``(2) The Secretary may remove from the list of standards 
established under paragraph (1) a standard which the Secretary 
determines is not reliable for the purpose set out in paragraph (1).
    ``(3) The Secretary shall accept a certification that a device 
conforms to a standard listed under paragraph (1), except that the 
Secretary may, at any time, request the person who submitted the 
certification to submit the data and information which such person 
relied upon in making such certification. A person who submitted such a 
certification shall maintain such data and information for a period of 
2 years after the submission of such certification.''.
    (b) Conforming Amendments.--
            (1) Section 514(a).--Section 514(a) (21 U.S.C. 360d(a)) is 
        amended by striking ``established under this section'' each 
        place it occurs and inserting ``established under subsection 
        (b) or listed under subsection (c)''
            (2) Adulterated device.--Section 501(e) (21 U.S.C. 351(e)) 
        is amended by striking ``established'' and inserting 
        ``established or listed''.
            (3) Prohibited acts.--Section 301 (21 U.S.C. 331) is 
        amended by adding at the end the following:
    ``(u) The falsification of a certification under section 514(c)(3) 
or the failure or refusal to provide data or information requested by 
the Secretary under such section.''.
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