What is it?
The FDA Quality System Regulation (QSR) is a set of regulations established by the U.S. Food and Drug Administration (FDA) that governs the quality management system for medical device manufacturers in the United States. The QSR is designed to ensure that medical devices are safe and effective for their intended use.
QSR contains several elements from ISO 13485 however they are not exactly the same. There are several specific requirements that are present in QSR that are absent in ISO 13485.
Unlike most countries, US FDA does not require a QMS certification (like ISO 13485 certificate) to prove that the manufacturer is fulfilling to QSR requirements. Instead, US FDA conducts pre-announced inspections personally to check on compliance. US FDA could also perform random unannounced inspections on the manufacturers if they want.
Why is QSR for US important?
These elements collectively form the FDA Quality System Regulation, which aims to ensure that medical devices meet rigorous standards of safety, effectiveness, and quality. Compliance with these regulations is essential for medical device manufacturers to gain FDA approval and maintain their ability to market and sell devices in the United States.