3.0.0 1736 2023-01-11T13:35:31Z 2023-01-11T13:35:31Z House HR 2017-03-27 115 [Congressional Record Volume 163, Number 53 (Monday, March 27, 2017)]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. BUCSHON:H.R. 1736.Congress has the power to enact this legislation pursuantto the following:Article 1, Section 8, Clause 3 of the United StatesConstitution[Page H2464]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2017-03-31T13:14:48Z Referred to 2017-03-27T16:02:40Z A bill to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments for granting export certifications. 115 404 S 2017-02-15 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Identical bill CRS 2017-03-31 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2017-03-27 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2017-03-27 Introduced in House IntroReferral Intro-H 9 Library of Congress 2017-03-27 Introduced in House IntroReferral 1000 9 Library of Congress B001275 Rep. Bucshon, Larry [R-IN-8] Larry Bucshon R IN 8 N B001284 Rep. Brooks, Susan W. [R-IN-5] Susan Brooks R IN W. 5 2017-03-27 True P000608 Rep. Peters, Scott H. [D-CA-52] Scott Peters D CA H. 52 2017-03-27 True B001251 Rep. Butterfield, G. K. [D-NC-1] G. K. Butterfield D NC 1 2017-03-27 True B001243 Rep. Blackburn, Marsha [R-TN-7] Marsha Blackburn R TN 7 2017-04-14 False B001299 Rep. Banks, Jim [R-IN-3] Jim Banks R IN 3 2017-04-25 False H001067 Rep. Hudson, Richard [R-NC-8] Richard Hudson R NC 8 2017-04-27 False R000592 Rep. Rokita, Todd [R-IN-4] Todd Rokita R IN 4 2017-06-21 False G000583 Rep. Gottheimer, Josh [D-NJ-5] Josh Gottheimer D NJ 5 2017-06-21 False Health Administrative law and regulatory procedures Department of Health and Human Services Drug safety, medical device, and laboratory regulation Health technology, devices, supplies Manufacturing Health 00 2017-03-27 Introduced in House 2017-08-29T12:37:25Z This bill amends the Federal Food, Drug, and Cosmetic Act to revise provisions regarding Food and Drug Administration (FDA): (1) inspections of establishments that manufacture or process medical devices, and (2) certification of medical devices for export.

The biannual inspection schedule for medical device establishments handling higher risk devices is replaced with a risk-based schedule. In establishing the risk-based schedule, the FDA must consider an establishment's participation in international medical device audit programs.

The FDA must adopt a uniform process and uniform standards for inspections of domestic and foreign medical device establishments.

Upon request, the FDA must provide to the person in charge of a medical device establishment feedback regarding the person's proposals to address issues identified during an inspection.

The FDA must provide the basis for denying requests for certification of products for export as meeting FDA requirements for domestic products. A person denied such a certification may request supervisory review of that decision.

Products from a medical device establishment that an inspector found to be contaminated or insanitary may be certified for export if the person in charge of the establishment has agreed to a plan to correct the issues identified during the inspection.]]> To amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications. Display Title To amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications. Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications. Introduced in House IH Introduced in House 2017-03-27T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-115hr1736ih/xml/BILLS-115hr1736ih.xml 2017-03-31 Referred to the Subcommittee on Health. 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.