FDA (Food and Drug Administration)

The FDA (Food and Drug Administration) regulates a broad variety of products and items intended for human and animal consumption. The FDA also is responsible for granting approval to new medical devices, from tongue depressors to pacemakers. It is one of 12 operating divisions within the U.S. Department of Health and Human Services and is overseen by the Secretary of HHS.

A Brief History of the FDA

While the federal government has played a role in consumer protection since the mid-1800s, the FDA’s origin can be traced to the passage of the Pure Food and Drugs Act in 1906. This act prohibited misbranded and adulterated food and drugs in interstate commerce, and came about in large part due to the efforts of chemist Harvey Washington Wiley, who headed the Bureau of Chemistry in the U.S. Department of Agriculture. In 1938, after an unregulated pharmaceutical killed scores of patients, Congress passed the Food, Drug and Cosmetic Act to tighten federal controls over drugs and food. This law is still in force today, and is a major guide for the FDA, in addition to regulations and FDA Good Guidance Practice.

The FDA and Spine Health

The FDA has a huge influence on the field of spine health, particularly when it comes to conventional surgery. Every device used by orthopedic specialists to alleviate back or neck pain requires FDA approval – or at least clearance or listing – including the rods, screws, plates, and other implants required for fusion surgery. The FDA also has a say in which pain medications are approved, as well as the advertising for prescription drugs and medical devices.