H.R.3493 - Medical Devices Technical Corrections Act108th Congress (2003-2004)
|Sponsor:||Rep. Greenwood, James C. [R-PA-8] (Introduced 11/17/2003)|
|Committees:||House - Energy and Commerce | Senate - Health, Education, Labor, and Pensions|
|Latest Action:||01/28/2004 Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.|
|Major Recorded Votes:||01/27/2004 : Passed House|
|Notes:||For further action, see S. 1881, which became Public Law 108-214 on 4/1/2004.|
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Summary: H.R.3493 — 108th Congress (2003-2004)All Bill Information (Except Text)
Passed House without amendment (01/27/2004)
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.
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.