Important Notice: Our web hosting provider recently started charging us for additional visits, which was unexpected. In response, we're seeking donations. Depending on the situation, we may explore different monetization options for our Community and Expert Contributors. It's crucial to provide more returns for their expertise and offer more Expert Validated Answers or AI Validated Answers. Learn more about our hosting issue here.

For products with an applicable FDA mandatory radiation safety performance standard, are there any other standards that FDA will accept?

April 26, 2017applicable fda mandatory PERFORMANCE products radiation safety standard Standards

0

Posted

For products with an applicable FDA mandatory radiation safety performance standard, are there any other standards that FDA will accept?

1 Answer

0

Posted

With the exception of the provision of Laser Notice 50 (http://www.fda.gov/cdrh/comp/guidance/1346.html), all products with an applicable standard must comply with the U.S. FDA’s standard before entering the U.S. or its territories. FDA does not recognize regulatory approvals from other countries or other organizations.