Regulatory Open Forum

Hello, 

According to FDA's website (https://www.fda.gov/about-fda/fda-basics/what-does-fda-do) "FDA's responsibilities extend to the 50 United States, the District of Columbia, Puerto Rico, Guam, the Virgin Islands, American Samoa, and other U.S. territories and possessions."

Based on this, is safe to assume that any approval or clearance of a medical device by FDA means that it is also approved in these territories? I cannot seem to find an exact reference in the regulations that addresses this.

Are there any mutual recognition agreement between these territories and US mainland?

Thanks! 

Hello,

yes you can assume that medical devices that are cleared via 510(k), approved via PMA can be marketed in the US territories and possessions. This has been my experience with class II,III devices and IVDs.

Your local distributor/representative in said territory will advise if there any addititional requirements such as pallet labeling in the local language etc

Joseph Califano

Hello, 

According to FDA's website (https://www.fda.gov/about-fda/fda-basics/what-does-fda-do) "FDA's responsibilities extend to the 50 United States, the District of Columbia, Puerto Rico, Guam, the Virgin Islands, American Samoa, and other U.S. territories and possessions."

Based on this, is safe to assume that any approval or clearance of a medical device by FDA means that it is also approved in these territories? I cannot seem to find an exact reference in the regulations that addresses this.

Are there any mutual recognition agreement between these territories and US mainland?

Thanks!