Skip to main content
HR 1494 110th Congress House Health Biomedical engineering Business records Child health Commerce Congress Congressional investigations Congressional reporting requirements Data banks Department of Health and Human Services Economics and Public Finance Electronic data interchange Families Federal advisory bodies Food and Drug Administration (FDA) Government Operations and Politics Government paperwork Government publicity Grants-in-aid Health information systems

Pediatric Medical Device Safety and Improvement Act of 2007

Introduced: March 13, 2007 Introduced by: Markey, Edward J. Democratic · Massachusetts See on congress.gov
Sign in to write a letter Sign in to watch
 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Mar 14, 2007
Referred to the Subcommittee on Health.
Mar 13, 2007
Referred to the House Committee on Energy and Commerce.
Mar 13, 2007
Introduced in House
 Plain-English summary Congressional Research Service

Pediatric Medical Device Safety and Improvement Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require an application for the approval of a medical device or a product development protocol to include: (1) a description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure; and (2) the number of affected pediatric patients.

Excludes a medical device distributed pursuant to the humanitarian device exemption from the prohibition that no device be sold for an amount that exceeds the cost of the device if: (1) the device is intended for the treatment or diagnosis of a disease or condition that occurs in pediatric patients; and (2) other specified requirements are met.

Requires the Director of the National Institutes of Health (NIH) to designate a contact point to help innovators and physicians access funding for pediatric medical device development.

Requires the Secretary of Health and Human Services to award grants for demonstration projects to promote pediatric device development.

Includes as a duty of the Office of Pediatric Therapeutics increasing pediatric access to medical devices.

Allows the Secretary to require: (1) postmarket surveillance on certain devices that are expected to have significant use in pediatric populations; and (2) a prospective surveillance period of more than 36 months for such devices, as necessary.

Requires the Secretary, acting through the Commissioner of Food and Drugs, to establish a publicly accessible database of all studies and surveillance of medical devices.

What's happening now March 14, 2007

Referred to the Subcommittee on Health.

 Committees of jurisdiction 2