3.0.0 2737 2023-01-11T13:31:42Z 2023-01-11T13:31:42Z Senate S 2016-03-17 114 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2016-03-17T20:59:53Z To amend the Federal Food, Drug, and Cosmetic Act with respect to the recognition of standards. 114 2425 HR 2015-05-22 Referred to the Subcommittee on Health. Related bill CRS To amend the Federal Food, Drug, and Cosmetic Act with respect to easing regulatory burden with respect to certain class I and class II devices. 114 2426 HR 2015-05-22 Referred to the Subcommittee on Health. Related bill CRS To amend the Federal Food, Drug, and Cosmetic Act with respect to advisory committee process. 114 2427 HR 2015-05-22 Referred to the Subcommittee on Health. Related bill CRS 2016-03-17 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2016-03-17 Introduced in Senate IntroReferral 10000 9 Library of Congress K000367 Sen. Klobuchar, Amy [D-MN] Amy Klobuchar D MN N R000307 Sen. Roberts, Pat [R-KS] PAT ROBERTS R KS 2016-03-17 True Health Administrative law and regulatory procedures Congressional oversight Department of Health and Human Services Drug safety, medical device, and laboratory regulation Food and Drug Administration (FDA) Government studies and investigations Health technology, devices, supplies Technology assessment Health 00 2016-03-17 Introduced in Senate 2016-12-19T20:13:30Z Improving Medical Device Innovation Act

This bill amends the Federal Food, Drug, and Cosmetic Act to revise provisions related to medical device performance standards, reporting requirements, and classification panels.

A person may request that the Food and Drug Administration (FDA) recognize a performance standard established by a recognized standards organization as a standard to which a medical device may conform in order to meet an FDA requirement. When a request to recognize a standard is received, the FDA must determine whether to recognize all, part, or none of the standard and publish the rationale for that determination. (Currently, the FDA recognizes certain performance standards, but it is not required to respond to requests or publish rationales.)

The FDA must:

  • train employees who review premarket submissions for medical devices on recognized standards;
  • review its published principles for recognizing standards;
  • identify types of medical devices for which a premarket report is no longer needed to provide reasonable assurance of safety and effectiveness;
  • ensure that adequate expertise is represented on medical device classification panels;
  • provide an opportunity for a person whose premarket submission is subject to review by a classification panel to recommend expertise needed on the panel; and
  • provide opportunities for patients, patient representatives, and medical device sponsors to recommend individuals for positions on classification panels.
The FDA, in coordination with medical device manufacturers, must establish pilot projects to evaluate alternative methods of compliance with reporting requirements for certain medical devices. The Government Accountability Office must report on these pilot projects.]]> Improving Medical Device Innovation Act Display Title Improving Medical Device Innovation Act Official Title as Introduced A bill to improve medical device innovation. Introduced in Senate IS Short Titles as Introduced Improving Medical Device Innovation Act Introduced in Senate 2016-03-17T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114s2737is/xml/BILLS-114s2737is.xml 2016-03-17 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.