3.0.0 1622 2023-01-11T13:30:40Z 2023-01-11T13:30:40Z Senate S 2015-06-18 114 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Reported by 2016-04-18T22:33:43Z Markup by 2016-02-09T15:08:34Z Referred to 2015-06-18T19:31:51Z 2016-04-18 Senate Placed on Senate Legislative Calendar under General Orders. Calendar No. 426. Calendars 2016-04-18 sshr00 Health, Education, Labor, and Pensions Committee Senate Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report. Committee 2016-04-18 Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report. Committee 14000 9 Library of Congress sshr00 Health, Education, Labor, and Pensions Committee 2016-02-09 sshr00 Health, Education, Labor, and Pensions Committee Senate Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably. Committee 2015-06-18 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2015-06-18 Introduced in Senate IntroReferral 10000 9 Library of Congress B001135 Sen. Burr, Richard [R-NC] Richard Burr R NC Mauze N F000457 Sen. Franken, Al [D-MN] Al Franken D MN 2015-06-18 True K000360 Sen. Kirk, Mark Steven [R-IL] MARK KIRK R IL STEVEN 2015-10-05 False E000285 Sen. Enzi, Michael B. [R-WY] MICHAEL ENZI R WY B. 2016-02-08 False A000360 Sen. Alexander, Lamar [R-TN] Lamar Alexander R TN 2016-02-10 False 2016-07-12T18:17:21Z S. 1622, FDA Device Accountability Act of 2016 https://www.cbo.gov/publication/51793 As reported by the Senate Committee on Health, Education, Labor and Pensions on April 18, 2016 Health Accounting and auditing Administrative law and regulatory procedures Department of Health and Human Services Drug safety, medical device, and laboratory regulation Food and Drug Administration (FDA) Government employee pay, benefits, personnel management Government studies and investigations Health technology, devices, supplies Health 00 2015-06-18 Introduced in Senate 2016-01-07T22:21:23Z FDA Device Accountability Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to ensure that employees who review premarket submissions of medical devices receive training on least burdensome requirements. (Currently, the FDA is required to consider the least burdensome appropriate means for a device sponsor to demonstrate the effectiveness of a device or its substantial equivalence to an approved device.) The FDA must periodically assess the implementation of those requirements.

The ombudsman for any applicable unit of the FDA must conduct an audit of the training on least burdensome requirements.

The FDA must consider: (1) the least burdensome appropriate means necessary to demonstrate device safety and effectiveness when requesting additional information from a device sponsor to support a premarket approval application, and (2) whether the least burdensome means would be reliance on postmarket information. The documentation of rationale for an applicable significant decision must include an explanation of how the least burdensome requirements were considered and applied.

The Institutional Review Board responsible for reviewing the plan for the clinical testing of a medical device no longer needs to be local to the facilities where the testing will be conducted.

The Department of Health and Human Services must revise its guidance entitled "Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices."]]> 01 2016-04-18 Reported to Senate with amendment(s) 2017-01-04T15:56:55Z FDA Device Accountability Act of 2016

(Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act to eliminate the requirement for the Institutional Review Board supervising the clinical testing of an investigational or humanitarian medical device to be local.

(Sec. 3) The Food and Drug Administration (FDA) must revise the guidance entitled “Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices.”

(Sec. 4) The FDA must ensure that employees who review premarket submissions of medical devices receive training on least burdensome means requirements. (Currently, the FDA is required to consider the least burdensome appropriate means for a sponsor to demonstrate the effectiveness of a medical device or demonstrate a device’s substantial equivalence to an approved medical device.) The FDA must periodically assess the implementation of those requirements. The ombudsman for any applicable unit of the FDA must audit and report on the training.

The FDA must consider the least burdensome appropriate means necessary to demonstrate medical device safety and effectiveness when requesting additional information from a device sponsor to support a premarket approval application, including the role of postmarket information in such a demonstration.

The FDA’s documented rationale for a significant decision regarding a medical device must include a statement regarding how the least burdensome requirements were considered and applied.]]> FDA Device Accountability Act of 2016 Display Title FDA Device Accountability Act of 2016 Official Title as Introduced A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to devices. Introduced in Senate IS Short Titles as Reported to Senate FDA Device Accountability Act of 2016 S Senate Short Titles as Introduced FDA Device Accountability Act of 2015 Reported to Senate 2016-04-18T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114s1622rs/xml/BILLS-114s1622rs.xml Introduced in Senate 2015-06-18T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114s1622is/xml/BILLS-114s1622is.xml 2016-04-18 Placed on Senate Legislative Calendar under General Orders. Calendar No. 426. 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.