Health Care Reform: What FDA-Regulated Industries Need to Know
On March 23, 2010, President Obama signed into law H.R. 3590, the Patient Protection and Affordable Care Act (Public Law 111-148). A companion bill, H.R. 4872, the Health Care Education Affordability Reconciliation Act of 2010, was signed into law on March 30. Together, these bills represent the most comprehensive overhaul ever enacted of both the public and private health care systems in the United States.
While the legislation will have a far-reaching impact on all segments of the health care and insurance industries, this document focuses more narrowly on some of the provisions that most directly affect the FDA-regulated industries in the areas of clinical trials, medical devices, health care fraud and disclosure requirements.
