S.2193 - Ensuring Safe Medical Devices for Patients
A bill to require the Food and Drug Administration to include devices in the postmarket risk identification and analysis system, to expedite the implementation of the unique device identification system for medical devices, and for other purposes.
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To require the Food and Drug Administration to include devices in the postmarket risk identification and analysis system, to expedite the implementation of the unique device identification system for medical devices, and for other purposes.CommentsClose CommentsPermalink
Mr. MERKLEY (for himself, Mr. GRASSLEY, Mr. BENNET, and Mr. KOHL) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and PensionsCommentsClose CommentsPermalink
To require the Food and Drug Administration to include devices in the postmarket risk identification and analysis system, to expedite the implementation of the unique device identification system for medical devices, and for other purposes.CommentsClose CommentsPermalink
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,CommentsClose CommentsPermalink
SEC. 2. ACTIVE POSTMARKET RISK IDENTIFICATION AND ANALYSIS.
(a) Records and Reports on Devices- Section 519 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i) is amended by inserting after subsection (c) the following:CommentsClose CommentsPermalink
‘(d) Inclusion of Devices in the Postmarket Risk Identification and Analysis System- Not later than 90 days after the date of enactment of the Ensuring Safe Medical Devices for Patients, the Secretary shall amend the procedures established and maintained under section 505(k)(3)(C) in order to expand the postmarket risk identification and analysis system established under such section to include and apply to devices in a comparable manner as such system includes and applies to drugs. The Secretary shall ensure that such amendments to the procedures shall give priority for inclusion in the postmarket risk identification and analysis system to class III and class II devices that are implantable, life-supporting or life-sustaining, or pose significant risk to users.’.CommentsClose CommentsPermalink
(b) Unique Device Identification System- Section 519(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i(f)) is amended--CommentsClose CommentsPermalink
(1) by striking ‘The Secretary shall promulgate’ and inserting ‘Not later than December 31, 2012, the Secretary shall issue final’; andCommentsClose CommentsPermalink
‘The Secretary shall implement the unique device identification system under this subsection not later than 1 year after the date on which the final regulations are issued.’.CommentsClose CommentsPermalink
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U.S. Congress - Text of S.2193 as Introduced in Senate Ensuring Safe Medical Devices for Patients
