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United States · Law · S

S. 1881 (108th)

Medical Devices Technical Corrections Act

enactedUnited States· United States Congress· EN

Introduced

18 November 2003

Last action

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Status

Became Public Law No: 108-214.

Sponsors

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Subjects

Discovery layer

Source updated

21 April 2025

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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 medical device fee schedule provisions. Revises facility inspection and accredited inspector provisions, including permitting a company that markets at least one medical device in the United States and one medical device in another country to satisfy inspection requirements by: (1) certifying that a foreign country recognizes Food and Drug Administration (FDA) inspection; and/or (2) marketing its devices in a country that recognizes third party inspectors. (Current law requires a company to meet both requirements.) Includes within permitted electronic labeling provisions in vitro diagnostic devices intended for use by health care professionals or in blood establishments. Extends the effective date of the provision deeming a device introduced into interstate commerce to be misbranded if the identification of the manufacturer is not conspicuously displayed from 18 months to 36 months after enactment of the Medical Device User Fee and Modernization Act of 2002 (October 26, 2002). Permits a person to sell a device under the humanitarian exemption from certain effectiveness requirements for more than its research, fabrication, and distribution costs if: (1) such device is intended for pediatric treatment or diagnosis; and (2) the exemption request is made on or after October 1, 2007. (Defines "pediatric patient" as a patient under 14 years old at the time of treatment or diagnosis.)

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Documents

21 official files

Enrolled Bill (text)

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