S. 3020, The Food and Drug Administration Accountability and Transparency Act

• This item is from the 110th Congress (2007-2008) and is no longer current. Comments, voting, and wiki editing have been disabled, and the cost/savings estimate has been frozen.

Version saved on August 21, 2008, 20:04:42, by webmaster:

S. 3020 would amend the Federal Food, Drug, and Cosmetic Act with respect to the postmarket surveillance of devices.

Detailed Summary

Food and Drug Administration Accountability and Transparency Act - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to publish in the Federal Register postmarket surveillance plans for medical devices, unless such information is exempted under the Freedom of Information Act.

Subjects medical device manufacturers that fail to comply with postmarket surveillance requirements to civil monetary penalties. Requires the Secretary to take into consideration whether the manufacturer is making efforts toward correcting the violation in determining the amount of the civil penalty.

Authorizes the Secretary to order notification of health personnel and other relevant persons if a violation of postmarket surveillance requirements of a device presents an unreasonable risk of substantial harm to the public health, such notification is necessary to eliminate such risk, and no more practicable means is available to eliminate such risk.

Status of the Legislation

Latest Major Action: 5/15/2008: Referred to Senate committee. Status: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Points in Favor

(Log in to edit the wiki and be the first to show why the bill should pass!)

Points Against

(Log in to edit the wiki and be the first to show why the bill should not pass!)

« Return to Revision History.