H.R. 3493: Medical Devices Technical Corrections Act

108th Congress · introduced 2003-11-17 · Health · Latest: Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

federal

Follow this bill, step by step

Where it came from: introduced 2003-11-17 · official record
Who proposed it: Rep. Greenwood, James C. [R-PA-8] · what a sponsor is
What happened next: 1 recorded vote in our records. Latest: House roll call 7 (2004): On Motion to Suspend the Rules and Pass, as Amended, HR3493 (2004-01-27), Passed. See all
Where it stands now: Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Not final yet: this can still change. We check for updates every day.
If it becomes law and spends money: follow the money to money laws, then agencies and contracts and grants.

What does this mean?

Official title

Medical Devices Technical Corrections Act

Plain summary

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. 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.

Congressional Research Service summary (Passed House without amendment), quoted unchanged (nonpartisan). Read the source.

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What does this mean? (plain words)

Official text

Medical Devices Technical Corrections Act

Source: Congressional Research Service summary (Passed House without amendment)

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How did my representative vote? · This bill's floor votes

Officials and money

Sponsor: Rep. Greenwood, James C. [R-PA-8] · 1 cosponsors

Cost estimate: No cost estimate published yet.

Cosponsors on this site

Recorded votes

House roll call 7 (2004): On Motion to Suspend the Rules and Pass, as Amended, HR3493 (2004-01-27): Passed

Words on this page, explained (3)

Appropriation: Money a legislature sets aside by law for a specific purpose. Government agencies may spend public money only as it has been appropriated.
Fiscal year: The 12-month period a government uses for its budget. The federal fiscal year runs from October 1 to September 30 and is named for the calendar year in which it ends. Most states use July 1 to June 30.
Rulemaking: The process agencies use to write regulations that carry out laws passed by Congress or a legislature. Usually an agency publishes a proposed rule, takes public comments, then publishes a final rule.

Plain meanings written from linked sources. All words.

Sources

Congressional Research Service summary (Passed House without amendment)
Congress.gov
Data: GovInfo BILLSTATUS bulk data (Library of Congress), BILLSTATUS-108hr3493.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/108/hr>

Record fed-us-cong108-hr3493 · catalog fed-us-congress-bills-cong108 · updated 2026-11-15 by psicol fed-bills-cong108