ISO information on ISO 13485:2016 standard
2018. 09. 05.

We kindly inform that FDA plans to use ISO 13485 for medical devices regulation as follows:

„The US Food and Drug Administration (FDA), the government department that regulates the medical devices sector, announced its intention to 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. Published in 2016, it is designed to work with other management systems in a way that is efficient and transparent. The standard, which is now in its third edition, received strong support from the FDA, in line with its drive for global convergence of medical device regulatory processes.

The announcement by the FDA that it will use ISO 13485 in replacing its current quality system regulation, is an important next step in the recognition this standard has already gained globally.”

Link to the original site to the ISO webpage: https://www.iso.org/news/ref2318.html

4 September 2018