Case Study

The US FDA to rely on ISO 13485 for medical devices

The US Food and Drug Administration (FDA), the government department that regulates the medical devices sector, will use ISO 13485 as the basis for its quality system legislation.

ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes, is the International Standard for quality management systems for the medical devices sector. The FDA strongly supports the standard, in line with its drive for global convergence of medical device regulatory processes.

This move by the FDA to use ISO 13485 in replacing its current quality system regulation, is an important next step in the recognition this standard has already gained globally.

Further information is available on the ISO website.