PlainBillCongress, translated.Legislation. Context. Public interest.Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Congressional Research Service
Version 81 · Passed House without amendment · Jan 27, 2004
Medical Devices Technical Corrections Act - Amends the Federal Food, Drug, and Cosmetic Act (as amended by the Medical Device User Fee and Modernization Act of 2002) to revise provisions concerning medical devices user fees.
Prohibits the Secretary of Health and Human Services from collecting fees to defray costs in any fiscal year where the amount appropriated is more than five percent below the costs of the resources allocated for the review of device applications.
Allows the Secretary to withdraw the accreditation to inspect from any person where the Secretary has information indicating a relationship between the company and the accredited inspector that may create a conflict of interest.
Showing the opening paragraphs of the official summary.
Permits a company that markets at least one medical device in the United States and one medical device in another country to use an accredited third party inspector if the company certifies that the foreign country recognizes inspections by: (1) the Food and Drug Administration (FDA); and/or (2) the third party inspector. (Current law requires a country to recognize both types of inspections.)
Allows the Secretary to withdraw eligibility for third party inspections from a company if the Secretary obtains information indicating significant deviations from compliance with the Act or implementing regulations.
Allows electronic labeling for prescription devices intended for use by health care professionals and for in vitro diagnostic devices intended for use by health care professionals or in blood establishments.
Delays by 18 additional months the effective date of the provision deeming a device misbranded if the identification of the manufacturer is not conspicuously displayed.
Directs the Secretary to submit a report to the relevant committees on the barriers to the availability of devices intended for treatment or diagnosis of diseases or conditions that affect children.
People & committees
Rep. Greenwood, James C. [R-PA-8] · R–PA
Legislative record
A procedural vote is different from passage. Passage in one chamber does not establish enactment. Explore the glossary.
Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Motion to reconsider laid on the table Agreed to without objection.
On motion to suspend the rules and pass the bill Agreed to by the Yeas and Nays: (2/3 required): 333 - 0 (Roll no. 7). (CR H109-110)
House roll call 7 · Individual votesPassed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by the Yeas and Nays: (2/3 required): 333 - 0 (Roll no. 7).(CR H109-110)
House roll call 7 · Individual votesConsidered as unfinished business. (consideration: CR H113)
At the conclusion of debate, the Yeas and Nays were demanded and ordered. Pursuant to the provisions of clause 8, rule XX, the Chair announced that further proceedings on the motion would be postponed.
DEBATE - The House proceeded with forty minutes of debate on H.R. 3493.
Considered under suspension of the rules. (consideration: CR H109-112)
Mr. Greenwood moved to suspend the rules and pass the bill.
Referred to the Subcommittee on Health.
Referred to the House Committee on Energy and Commerce.
Introduced in House
Introduced in House
Primary sources
Text links open the official source. We currently store references to these documents.
Source last updated: Apr 21, 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 H.R.3493 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 H.R.3493 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 H.R.3493 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 H.R.3493 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.