FDA Issues (Draft) Guidance on 510(k) Transfers

FDA has always allowed companies to transfer 510(k) clearances without obtaining new clearance. FDA allows allows a 510(k) holder to transfer clearance without a new 510(k) clearance (absent a significant modification of the device). There may be only one 510(k) holder at a time. The process has never been entirely clear.

Now the Agency has issued draft guidanbce in the form of Q & A.

For details see: FDA.

For a good blog on the subject, see the FDA Law Blog.

Posted by Tim Sandle