On September 27, 2007, President George W. Bush signed into law H.R. 3580, the Food and Drug Administration Amendments Act of 2007,1 and in so doing, amended the Federal Food, Drug and Cosmetic Act (“the Act”). The law represented a significant addition to the Food and Drug Administration’s (“FDA”) authority. On April 1, 2010, the FDA promulgated a Direct Final Rule2 implementing section 515A of the Act. Section 515A is also known as the Pediatric Medical Safety Device and Improvement Act of 2007.3

I. The Pediatric Medical Device Safety and Improvement Act of 2007

The Pediatric Medical Device Safety and Improvement Act of 2007 (“PMDSIA”) was introduced by Senator Chris Dodd on March 8, 2007.4 The purpose of the PMDSIA is to improve the process for the development of needed pediatric medical devices.5 According to Senator Dodd, the PMDSIA provides a comprehensive approach to ensuring that children are not left behind as cutting-edge research and revolutionary technologies for medical devices advance...