3.0.0 882 2023-01-11T13:19:22Z 2023-01-11T13:19:22Z Senate S S 2009-04-23 111 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2009-04-23T19:36:00Z 2009-04-23 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2009-04-23 Introduced in Senate IntroReferral 10000 9 Library of Congress K000105 Sen. Kennedy, Edward M. [D-MA] EDWARD KENNEDY D MA MOORE N G000386 Sen. Grassley, Chuck [R-IA] Charles Grassley R IA E. 2009-04-23 True Health Department of Health and Human Services Drug safety, medical device, and laboratory regulation Employment discrimination and employee rights Executive agency funding and structure Food and Drug Administration (FDA) Government information and archives Government studies and investigations Health technology, devices, supplies Licensing and registrations Prescription drugs Product safety and quality Trade restrictions User charges and fees Health 00 2009-04-23 Introduced in Senate 2009-06-18T17:43:58Z Drug and Device Accountability Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise provisions regarding the registration of drug and device establishments, including to: (1) expand the information required to be included in a registration; and (2) provide for risk-based inspections.

Includes in the definition of "drug" a precursor ingredient.

Requires the Secretary of Health and Human Services (HHS) to assess the registration exemption for manufacturers of harmless inactive ingredients that become components of drugs.

Deems a drug to be adulterated if certain conditions related to verification of identity and purity, identification of establishments, consistency with current manufacturing technologies, and conformity with good distribution and import practices are not met.

Deems a drug or device to be misbranded unless certain conditions related to labeling for country of manufacture and provision of required information on importation are met.

Sets forth provisions governing importation of a drug and its components.

Sets forth required actions, including cessation of distribution, if there is a reasonable probability that a drug intended for human use would cause serious, adverse health consequences or death.

Establishes actions manufacturers must take regarding any defective drug.

Sets forth additional required certifications for submissions related to drugs and devices regarding accuracy and personal knowledge of information submitted.

Establishes whistleblower protection for employees providing information regarding a drug, biological product, or device.

Requires the Secretary to contract with the Institute of Medicine to evaluate: (1) the organizational structure and operations of the Food and Drug Administration (FDA) with respect to the review of medical devices for clearance and for premarket approval under FFDCA; and (2) the analytical and methodological tools used to conduct such reviews.

Directs the Secretary to establish a corps of inspectors dedicated to inspections of foreign establishments and facilities.

Sets forth enforcement provisions.

]]> Drug and Device Accountability Act of 2009 Display Title Drug and Device Accountability Act of 2009 Official Title as Introduced A bill to amend the Federal Food, Drug, and Cosmetic Act to ensure the safety and quality of medical products and enhance the authorities of the Food and Drug Administration, and for other purposes. Introduced in Senate IS Short Titles as Introduced Drug and Device Accountability Act of 2009 Introduced in Senate 2009-04-23T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-111s882is/xml/BILLS-111s882is.xml 2009-04-23 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.