3.0.0 2067 2020-02-10T17:00:03Z 2020-02-10T17:00:03Z Senate S S 2012-02-02 112 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2012-02-02T22:01:44Z 2012-02-02 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2012-02-02 Introduced in Senate IntroReferral 10000 9 Library of Congress C001070 Sen. Casey, Robert P., Jr. [D-PA] Bob Casey D PA N M000303 Sen. McCain, John [R-AZ] JOHN MCCAIN R AZ SIDNEY 2012-02-02 True Health Administrative law and regulatory procedures Congressional oversight Department of Health and Human Services Food and Drug Administration (FDA) Government information and archives Health technology, devices, supplies Health 00 2012-02-02 Introduced in Senate 2012-05-09T21:14:36Z Safe, Efficient, and Transparent Medical Device Approval Act or the SET Device Act - Directs the Secretary of Health and Human Services (HHS), within 120 days of enactment of this Act, to establish the schedule for the promulgation of a regulation requiring premarket approval for a medical device that the Secretary requires to remain in class III.

Directs the Secretary, within 18 months, to: (1) issue a final regulation for each device that the Secretary requires to remain in class III, and (2) establish the required special controls for each device that is classified into class II pursuant to a determination revising such devise's classification.

Amends the Federal Food, Drug, and Cosmetic Act to permit a person to: (1) submit a request for initial classification of a device that has not previously been classified under such Act if the person declares that there is no legally marketed device upon which to base a substantial equivalence determination; and (2) recommend to the Secretary a classification for the device and include in the request an initial draft proposal for applicable special and general controls that are necessary to provide reasonable assurance of safety and effectiveness.

Permits the Secretary to decline to undertake a classification request if the Secretary identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence or if the Secretary determines that the device submitted is not of low-moderate risk.

]]> SET Device Act Short Titles as Introduced SET Device Act Short Titles as Introduced Safe, Efficient, and Transparent Medical Device Approval Act Display Title SET Device Act Official Title as Introduced A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to medical device regulation, and for other purposes. Introduced in Senate 2012-02-02T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-112s2067is/xml/BILLS-112s2067is.xml 2012-02-02 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.