In 1976, the U.S. Congress passed the Medical Device Amendments to ensure safety and effectiveness of medical devices, including diagnostic products. The amendments required manufacturers to register with FDA and follow quality control procedures.

The amendments created a three-class, risk-based classification system for all medical devices. They also established regulatory pathways for new medical devices (devices that were not on the market prior to May 28, 1976, or had been significantly modified) to get to market: Premarket Approval (PMA) and premarket notification (510(k)). Established the regulatory pathways for new medical devices (devices that were not on the market prior to May 28, 1976, or had been significantly modified) to get to market: Premarket Approval (PMA) and premarket notification (510(k).