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Medical Devices Technical Corrections Act

Introduced: November 18, 2003 See on congress.gov
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 Everywhere this bill has been 30 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Apr 1, 2004
Became Public Law No: 108-214.
Apr 1, 2004
Signed by President.
Mar 22, 2004
Presented to President.
Mar 15, 2004
Message on Senate action sent to the House.
Mar 12, 2004
Senate agreed to House amendment by Unanimous Consent. (text as Senate agreed to House amendment: CR S2821-2822)
Mar 12, 2004
Resolving differences -- Senate actions: Senate agreed to House amendment by Unanimous Consent.(text as Senate agreed to House amendment: CR S2821-2822)
Mar 11, 2004
Message on House action received in Senate and at desk: House amendment to Senate bill.
Mar 10, 2004
Motion to reconsider laid on the table Agreed to without objection.
Mar 10, 2004
On motion to suspend the rules and pass the bill, as amended Agreed to by the Yeas and Nays: (2/3 required): 396 - 0 (Roll no. 46). (text: CR 3/9/2004 H890-891)
Mar 10, 2004
Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by the Yeas and Nays: (2/3 required): 396 - 0 (Roll no. 46).(text: CR 3/9/2004 H890-891)
Mar 10, 2004
Considered as unfinished business. (consideration: CR H931-932)
Mar 9, 2004
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.
Mar 9, 2004
DEBATE - The House proceeded with forty minutes of debate on S. 1881.
Mar 9, 2004
Considered under suspension of the rules. (consideration: CR H890-892)
Mar 9, 2004
Mr. Greenwood moved to suspend the rules and pass the bill, as amended.
Mar 9, 2004
Placed on the Union Calendar, Calendar No. 250.
Mar 9, 2004
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 108-433.
Mar 3, 2004
Ordered to be Reported (Amended) by Voice Vote.
Mar 3, 2004
Committee Consideration and Mark-up Session Held.
Dec 17, 2003
Referred to the Subcommittee on Health.
Dec 8, 2003
Referred to the House Committee on Energy and Commerce.
Dec 8, 2003
Message on Senate action sent to the House.
Dec 8, 2003
Received in the House.
Nov 25, 2003
Passed Senate with an amendment by Unanimous Consent. (consideration: CR S16057-16060; text of measure as reported to Senate: CR S16058-16060)
Nov 25, 2003
Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.(consideration: CR S16057-16060; text of measure as reported to Senate: CR S16058-16060)
Nov 24, 2003
Placed on Senate Legislative Calendar under General Orders. Calendar No. 412.
Nov 24, 2003
Committee on Health, Education, Labor, and Pensions. Reported by Senator Gregg with an amendment in the nature of a substitute. Without written report.
Nov 21, 2003
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Nov 18, 2003
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Nov 18, 2003
Introduced in Senate
 Votes taken on this bill 1
DateChamberWhat was voted onResultYes–No
Mar 10, 2004 House · vote #46 On Motion to Suspend the Rules and Pass, as Amended Passed 396–0 See who voted →
 Plain-English summary Congressional Research Service

(This measure has not been amended since it was reported to the House on March 9, 2004. The summary of that version is repeated here.)

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 accreditation to inspect from any person where the Secretary determines that there is a conflict of interest between the company and the accredited inspector.

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 determines that the company is substantially not in compliance with the Act.

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.

What's happening now April 1, 2004

Became Public Law No: 108-214.

 Committees of jurisdiction 3
 Cosponsors 1
All 1 Democratic 1