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.

Bill: 114-hr-2426
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

Government information and archives

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 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.)</p> 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.

tv_txt: I 114th CONGRESS 1st Session H. R. 2426 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.

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. .