Dear All,
We are a UK based manufacturer of finished medical devices that we sell around the world, including the USA. Currently the electrical products are UL listed, but this is becoming increasingly expensive.
We are aware that there other bodies that offer a similar service to that provided by UL.
We have been advised that although the FDA don't require UL listing, many insurance companies do insist on their clients having UL (or similar) listing.
We are curious to know if the FDA would expect to see anything in place of a UL type listing (3rd party 60601 certification for example), and is the advice regarding insurance company requirements correct?
Thanks for your help.
Dave
We are a UK based manufacturer of finished medical devices that we sell around the world, including the USA. Currently the electrical products are UL listed, but this is becoming increasingly expensive.
We are aware that there other bodies that offer a similar service to that provided by UL.
We have been advised that although the FDA don't require UL listing, many insurance companies do insist on their clients having UL (or similar) listing.
We are curious to know if the FDA would expect to see anything in place of a UL type listing (3rd party 60601 certification for example), and is the advice regarding insurance company requirements correct?
Thanks for your help.
Dave