3.0.0 3020 2020-02-10T17:01:58Z 2020-02-10T17:01:58Z Senate S S 2008-05-15 110 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2008-05-15T18:04:18Z 2008-05-15 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2008-05-15 Introduced in Senate IntroReferral 10000 9 Library of Congress B000711 Sen. Boxer, Barbara [D-CA] BARBARA BOXER D CA N S000033 Sen. Sanders, Bernard [I-VT] Bernard Sanders I VT 2008-09-26 False Health Commerce Defective products Fines (Penalties) Government Operations and Politics Government publicity Law Medical supplies Medical technology Product safety Science, Technology, Communications Health 00 2008-05-15 Introduced in Senate 2008-08-21T19:35:09Z Food and Drug Administration Accountability and Transparency Act - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to publish in the Federal Register postmarket surveillance plans for medical devices, unless such information is exempted under the Freedom of Information Act.

Subjects medical device manufacturers that fail to comply with postmarket surveillance requirements to civil monetary penalties. Requires the Secretary to take into consideration whether the manufacturer is making efforts toward correcting the violation in determining the amount of the civil penalty.

Authorizes the Secretary to order notification of health personnel and other relevant persons if a violation of postmarket surveillance requirements of a device presents an unreasonable risk of substantial harm to the public health, such notification is necessary to eliminate such risk, and no more practicable means is available to eliminate such risk.

]]> Food and Drug Administration Accountability and Transparency Act Short Titles as Introduced Food and Drug Administration Accountability and Transparency Act Display Title Food and Drug Administration Accountability and Transparency Act Official Title as Introduced A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the postmarket surveillance of devices. Introduced in Senate 2008-05-15T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-110s3020is/xml/BILLS-110s3020is.xml 2008-05-15 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.