PlainBillCongress, translated.Legislation. Context. Public interest.Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Congressional Research Service
Version 00 · Introduced in Senate · Mar 17, 2016
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.)
Showing the opening paragraphs of the official summary.
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.
People & committees
Sen. Klobuchar, Amy [D-MN] · D–MN
Legislative record
A procedural vote is different from passage. Passage in one chamber does not establish enactment. Explore the glossary.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
Primary sources
Text links open the official source. We currently store references to these documents.
Source last updated: Aug 12, 2025. Consult Congress.gov for the current record.
AI Conversation Starters
Choose a perspective, copy a prompt, and paste it into your preferred AI. Each prompt includes the bill version and available official source links, and asks for counterarguments as well as supporting evidence.
Analyze S.2737 as objectively as possible. Explain its main provisions, who would be affected, possible benefits and harms, implementation, exceptions, and uncertainties. Present the strongest arguments for and against it, and identify evidence needed to assess its public impact.
Examine S.2737 through a progressive lens, focusing on fairness, access, economic inequality, and effects on vulnerable communities. Explain potential benefits, costs, and unintended consequences. Consider the strongest counterarguments and distinguish stated goals from demonstrated outcomes.
Examine S.2737 through a conservative lens, focusing on fiscal responsibility, institutional stability, federalism, and the scope of government. Explain potential benefits, costs, and unintended consequences. Consider the strongest counterarguments and any provisions that challenge this perspective.
Examine S.2737 through a civil-liberties and limited-government lens. Consider individual rights, privacy, voluntary choice, accountability, and government power. Explain tradeoffs, possible safeguards, and the strongest counterarguments without assuming the proposal is beneficial or harmful.