S.4098 - Pediatric Medical Device Safety and Improvement Act of 2006109th Congress (2005-2006)
Summary: S.4098 — 109th Congress (2005-2006)
Introduced in Senate (12/06/2006)
Pediatric Medical Device Safety and Improvement Act of 2006 - 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.
Requires the Secretary to adopt voluntary national standards for medical device coding.