3.0.0 1943 2023-01-11T13:22:58Z 2023-01-11T13:22:58Z Senate S S 2011-12-05 112 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2011-12-05T22:31:46Z 2011-12-05 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2011-12-05 Introduced in Senate IntroReferral 10000 9 Library of Congress B001268 Sen. Brown, Scott P. [R-MA] Scott Brown R MA P. N A000368 Sen. Ayotte, Kelly [R-NH] Kelly Ayotte R NH 2011-12-05 True Health Administrative remedies Department of Health and Human Services Drug safety, medical device, and laboratory regulation Food and Drug Administration (FDA) Health technology, devices, supplies Health 00 2011-12-05 Introduced in Senate 2012-05-04T21:55:00Z Novel Device Regulatory Relief Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to allow a person to request the Secretary of Health and Human Services (HHS) to classify a device regardless of whether the person has received written notice of classification into class III (premarket approval) under the initial classification procedures applicable to devices introduced or delivered for introduction into interstate commerce before May 28, 1976.

Allows a person that is required to submit a report preceding the introduction of device into interstate commerce, and determines that there is no legally marketed device upon which to base a determination of substantial equivalence, to request an initial classification of the device and to recommend to the Secretary a classification. Allows the Secretary to decline to undertake such a request when the Secretary identifies a legally marketed device that would permit a determination of substantial equivalence.

]]> Novel Device Regulatory Relief Act of 2011 Display Title Novel Device Regulatory Relief Act of 2011 Official Title as Introduced A bill to amend section 513 of the Federal Food, Drug, and Cosmetic Act to expedite the process for requesting de novo classification of a device. Introduced in Senate IS Short Titles as Introduced Novel Device Regulatory Relief Act of 2011 Introduced in Senate 2011-12-05T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-112s1943is/xml/BILLS-112s1943is.xml 2011-12-05 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.