To allow for devices with a predetermined change control plan to be marketed without submitting a supplemental application or premarket notification if the changes to such devices are consistent with such plan.

3.0.0 4386 2022-12-29T17:48:36Z 2022-12-29T17:48:36Z Senate S 2022-06-13 117 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2022-06-13T22:26:09Z To allow for devices with a predetermined change control plan to be marketed without submitting a supplemental application or premarket notification if the changes to such devices are consistent with such plan. 117 8299 HR 2022-07-07 Referred to the House Committee on Energy and Commerce. Identical bill CRS 2022-06-13 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2022-06-13 Introduced in Senate IntroReferral 10000 9 Library of Congress B001310 Sen. Braun, Mike [R-IN] Mike Braun R IN N H000273 Sen. Hickenlooper, John W. [D-CO] John Hickenlooper D CO W. 2022-06-13 True Health Health

00 2022-06-13 Introduced in Senate 2022-10-21T20:34:48Z This bill allows changes to be made to medical devices without the need for supplemental applications or premarket notifications if the changes are made in accordance with a predetermined change control plan.

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A bill to allow for devices with a predetermined change control plan to be marketed without submitting a supplemental application or premarket notification if the changes to such devices are consistent with such plan. Display Title A bill to allow for devices with a predetermined change control plan to be marketed without submitting a supplemental application or premarket notification if the changes to such devices are consistent with such plan. Official Title as Introduced A bill to allow for devices with a predetermined change control plan to be marketed without submitting a supplemental application or premarket notification if the changes to such devices are consistent with such plan. Introduced in Senate IS Introduced in Senate 2022-06-13T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-117s4386is/xml/BILLS-117s4386is.xml 2022-06-13 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.