Medical Devices Technical Corrections Act

Bill: 108-hr-3493
Sponsor: Rep. Greenwood, James C. [R-PA-8]
Introduced: 2003-11-17 in the House
Policy area: Health
Subjects: Accreditation (Medical care)
Administrative remedies
Artificial implants
Business records
Child health
Commerce
Department of Health and Human Services
Economics and Public Finance
Families
Federal aid to research
Food and Drug Administration (FDA)
Government Operations and Politics
Government paperwork
Governmental investigations
Law
Manufacturing industries
Medical research
Medical supplies
Product safety
Prosthesis
Research grants
Science, Technology, Communications
User charges
Women
Women's health

Summary:
action_date: 2003-11-17
text: 
Medical Devices Technical Corrections Act of 2003 - 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.)
 
Eliminates the provision deeming a device introduced into interstate commerce within 18 months of enactment of the Medical Device User Fee and Modernization Act of 2002 (October 26, 2002) to be misbranded if the identification of the manufacturer is not conspicuously displayed.
 
Requires (currently authorizes) the Secretary of Health and Human Services to conduct or support research on the long-term effects of silicone breast implants.
 
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 such device is intended for pediatric treatment or diagnosis. (Defines &quot;pediatric patient&quot; as a patient under 15 years old at the time of treatment or diagnosis.)

action_date: 2004-01-27
text: 
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. 


Legislative actions:
action_date: 2004-01-28
text: Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
action_date: 2004-01-27
text: Motion to reconsider laid on the table Agreed to without objection.
action_date: 2004-01-27
text: 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)
action_date: 2004-01-27
text: Passed/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)
action_date: 2004-01-27
text: Considered as unfinished business. (consideration:  CR H113)
action_date: 2004-01-27
text: 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.
action_date: 2004-01-27
text: DEBATE - The House proceeded with forty minutes of debate on H.R. 3493.
action_date: 2004-01-27
text: Considered under suspension of the rules. (consideration:  CR H109-112)
action_date: 2004-01-27
text: Mr. Greenwood moved to suspend the rules and pass the bill.
action_date: 2003-12-04
text: Referred to the Subcommittee on Health.
action_date: 2003-11-17
text: Referred to the House Committee on Energy and Commerce.
action_date: 2003-11-17
text: Introduced in House
action_date: 2003-11-17
text: Introduced in House