FDA recognizes the third edition of ISO 14971

Navigation

FDA recognizes the third edition of ISO 14971

In December 2019, the third edition of the ISO 14971 standard - Application of risk management to medical devices has been published. The changes include a significant reorganization of content, new terms, and more detailed requirements around evaluating residual risks and collecting production and post-production information. For more details please refer to the following link:

https://www.merc21.it/news-detail.asp/l_en/id_51/published-the-new-iso-14971-2019-application-of-risk-management-to-medical-devices.html

FDA has granted Recognized Consensus Standard status to the third edition of the ISO 14971.

The US Food and Drug Administration will accept declarations of conformity to ISO 14971 2nd edition, 2007-03-01, in support of medical device and IVD premarket submissions until December 25, 2022. After this transition period, FDA medical device and IVD registrants will be required to provide declarations of conformity to the ISO 14971 standard’s third edition.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=40369