3.0.0 2292 2020-02-10T17:00:03Z 2020-02-10T17:00:03Z Senate S S 2012-04-17 112 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2012-04-17T22:05:15Z 2012-04-17 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2012-04-17 Introduced in Senate IntroReferral 10000 9 Library of Congress B001135 Sen. Burr, Richard [R-NC] Richard Burr R NC Mauze N C000560 Sen. Coburn, Tom [R-OK] TOM COBURN R OK 2012-04-17 True Health Administrative law and regulatory procedures Advisory bodies Africa Asia Australia Canada Computers and information technology Congressional oversight Department of Health and Human Services Drug safety, medical device, and laboratory regulation Europe European Union Food and Drug Administration (FDA) Government employee pay, benefits, personnel management Government information and archives Government studies and investigations Israel Japan Medical research Middle East New Zealand Oceania Performance measurement Prescription drugs South Africa Switzerland User charges and fees Health 00 2012-04-17 Introduced in Senate 2012-09-19T18:10:29Z Promoting Accountability, Transparency, Innovation, Efficiency, and Timeliness at FDA Act of 2012 or the PATIENTS' FDA Act - Requires the Secretary of Health and Human Services (HHS) to develop a strategy and implementation plan for advancing regulatory science for medical products in order to promote the public health and advance innovation in regulatory decision making.

Expands reporting requirements related to Food and Drug Administration (FDA) progress reports, generic drugs, and biosimilar products.

Requires the Secretary to: (1) document the scientific and regulatory rationale for any significant decision regarding drugs, biologics, or medical device applications; and (2) review all regulations and guidance of the FDA with respect to human medical products to ensure consistency with the requirements of the Federal Food, Drug, and Cosmetic Act (FFDCA) and specified regulatory principles.

Amends the FFDCA to require the Secretary to assess the safety and effectiveness of a medical device from the perspective of a reasonable patient in the intended use population.

Sets forth provisions governing determinations by the Secretary of a lack of reasonable assurance of safety of a device.

Requires the Secretary to implement a structured benefit-risk assessment framework in the new drug approval process.

Directs the FDA to foster and encourage uniform, scientifically-driven clinical trial standards around the world.

Sets forth provisions governing investigational exemptions for medical devices.

Requires the  Office of the Chief Counsel in the FDA to review a warning letter with respect to a drug or device before it is issued.

Sets forth provisions related to FDA advisory committees.

Revises provisions governing medical devices, including to require the Secretary to: (1) assign a tracking number to a medical device and assign an experienced reviewer to review the application; (2) revise the device submission acceptance criteria; and (3) regularly publish detailed decision summaries for each clearance of a device, substantial equivalence determination for a device, and each initial classification of a device. Sets forth the circumstances under which a medical device classification report must be submitted for a modification of a device.

Exempts medical devices modified to meet the individual needs of a specific patient from requirements to meet specified performance standards and premarket approval clearance if specified requirements are met.

Revises and extends through October 1, 2017, provisions authorizing accredited persons to provide classification reports for a medical device and to inspect class II or class III device facilities.

Requires the Secretary to submit a strategic integrated management plan for the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health.

Directs the Secretary to contract with a consulting firm to conduct a comprehensive assessment of the process for the review of drug, device, and biologics applications.

Requires the Comptroller General to report on activities under this Act.

]]> PATIENTS' FDA Act Short Titles as Introduced PATIENTS' FDA Act Short Titles as Introduced Promoting Accountability, Transparency, Innovation, Efficiency, and Timeliness at FDA Act of 2012 Display Title PATIENTS' FDA Act Official Title as Introduced A bill to promote accountability, transparency, innovation, efficiency, and timeliness at the Food and Drug Administration for America's patients. Introduced in Senate 2012-04-17T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-112s2292is/xml/BILLS-112s2292is.xml 2012-04-17 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.