FDAnews Device Daily Bulletin

Failure to Document Design Changes Lands Devicemaker a Warning Letter

March 12, 2013
A Feb. 22 FDA warning letter to TOADS LLC says the company’s products are adulterated because changes were made to them following the receipt of 510(k) clearance. According to investigators in the Cincinnati district office, the Louisville, Kty., devicemaker made seven design changes to various products.
Devices & Diagnostics Letter