FDA’s QMSR Final Rule Harmonizes U.S. and Intl. Device Requirements

The FDA has released its long-awaited Quality Management System Regulation (QMSR) final rule, including a change that requires medical device manufacturers to be compliant within two years instead of the originally proposed one year.

The final rule aligns the agency’s 27-year-old Quality System Regulation (QSR) with the ISO 13485 international standard in a major revision aimed at harmonizing domestic and international requirements for medical devices.

The FDA aims to reduce the regulatory burden by “streamlining actions device manufacturers must take to meet requirements by multiple regulatory authorities,” said Jeff Shuren, CDRH director, in announcing the release of the final rule.

Read the final rule here.

To read the whole story, click here to subscribe.

Related Topics