To amend the Federal Food, Drug, and Cosmetic Act with respect to easing regulatory burden with respect to certain class I and class II devices.

This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA), not later than 120 days after enactment of the 21st Century Cures Act (H.R. 6, a bill introduced on May 19, 2015), to identify types of class I medical devices (devices that do not need special controls to assure their safety and effectiveness) for which a report is no longer needed prior to marketing to provide reasonable assurance of safety and effectiveness. (Currently, a report is needed for a class I device only if the device is of substantial importance in preventing impairment of human health or if it presents a potential unreasonable risk of illness or injury.)

Not later than 180 days after enactment of the 21st Century Cures Act, the FDA must publish a list of types of class II medical devices (devices that need special controls to assure their safety and effectiveness) for which a report is no longer needed prior to marketing to provide reasonable assurance of safety and effectiveness. (Currently, such a list must be published each time the FDA exempts a type of class II device from the reporting requirement.) The public comment period for such an exemption is extended to 60 days.

[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2426 Introduced in House (IH)]

114th CONGRESS
  1st Session
                                H. R. 2426

   To amend the Federal Food, Drug, and Cosmetic Act with respect to 
 easing regulatory burden with respect to certain class I and class II 
                                devices.


_______________________________________________________________________


                    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 
 easing regulatory burden with respect to certain class I and class II 
                                devices.

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

SECTION 1. EASING REGULATORY BURDEN WITH RESPECT TO CERTAIN CLASS I AND 
              CLASS II DEVICES.

    (a) Class I Devices.--Section 510(l) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360(l)) is amended--
            (1) by striking ``A report under subsection (k)'' and 
        inserting ``(1) A report under subsection (k)''; and
            (2) by adding at the end the following new paragraph:
    ``(2) Not later than 120 days after the date of the enactment of 
the 21st Century Cures Act, the Secretary shall identify, through 
publication in the Federal Register, any type of class I device that 
the Secretary determines no longer requires a report under subsection 
(k) to provide reasonable assurance of safety and effectiveness. Upon 
such publication--
            ``(A) each type of class I device so identified shall be 
        exempt from the requirement for a report under subsection (k); 
        and
            ``(B) the classification regulation applicable to each such 
        type of device shall be deemed amended to incorporate such 
        exemption.''.
    (b) Class II Devices.--Section 510(m) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360(m)) is amended--
            (1) by striking paragraph (1) and inserting the following 
        new paragraph:
    ``(1) The Secretary shall--
            ``(A) not later than 60 days after the date of the 
        enactment of the 21st Century Cures Act--
                    ``(i) publish in the Federal Register a notice that 
                contains a list of each type of class II device that 
                the Secretary determines no longer requires a report 
                under subsection (k) to provide reasonable assurance of 
                safety and effectiveness; and
                    ``(ii) provide for a period of not less than 60 
                days for public comment beginning on the date of the 
                publication of such notice; and
            ``(B) not later than 180 days after the date of the 
        enactment of 21st Century Cures Act, publish in the Federal 
        Register a list representing the Secretary's final 
        determination with respect to the devices contained in the list 
        published under subparagraph (A).'';
            (2) in paragraph (2)--
                    (A) by striking ``1 day after the date of 
                publication of a list under this subsection,'' and 
                inserting ``1 day after the date of publication of the 
                final list under paragraph (1)(B),''; and
                    (B) by striking ``30-day period'' and inserting 
                ``60-day period''; and
            (3) by adding at the end the following new paragraph:
    ``(3) Upon the publication of the final list under paragraph 
(1)(B)--
            ``(A) each type of class II device so listed shall be 
        exempt from the requirement for a report under subsection (k); 
        and
            ``(B) the classification regulation applicable to each such 
        type of device shall be deemed amended to incorporate such 
        exemption.''.
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