PUBLIC LAW 110–85—SEPT. 27, 2007
121 STAT. 823
Public Law 110–85 110th Congress An Act To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs, and for other purposes.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Food and Drug Administration Amendments Act of 2007’’.
Sept. 27, 2007 [H.R. 3580]
Food and Drug Administration Amendments Act of 2007. 21 USC 301 note.
SEC. 2. TABLE OF CONTENTS.
The table of contents for this Act is as follows: Sec. 1. Short title. Sec. 2. Table of contents. TITLE I—PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007 Sec. Sec. Sec. Sec.
101. 102. 103. 104.
Sec. Sec. Sec. Sec. Sec.
105. 106. 107. 108. 109.
Short title; references in title; finding. Definitions. Authority to assess and use drug fees. Fees relating to advisory review of prescription-drug television advertising. Reauthorization; reporting requirements. Sunset dates. Effective date. Savings clause. Technical amendment; conforming amendment.
TITLE II—MEDICAL DEVICE USER FEE AMENDMENTS OF 2007 Sec. 201. Short title; references in title; finding. Subtitle A—Fees Related to Medical Devices Sec. Sec. Sec. Sec. Sec.
Definitions. Authority to assess and use device fees. Reauthorization; reporting requirements. Savings clause. Additional authorization of appropriations for postmarket safety information. Sec. 216. Effective date. Sec. 217. Sunset clause. Sec. Sec. Sec.
dkrause on GSDDPC44 with PUBLAW
Sec. Sec. Sec. Sec.
VerDate Aug 31 2005
211. 212. 213. 214. 215.
Subtitle B—Amendments Regarding Regulation of Medical Devices 221. Extension of authority for third party review of premarket notification. 222. Registration. 223. Filing of lists of drugs and devices manufactured, prepared, propagated, and compounded by registrants; statements; accompanying disclosures. 224. Electronic registration and listing. 225. Report by Government Accountability Office. 226. Unique device identification system. 227. Frequency of reporting for certain devices.
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