Double Check Flash Drives Before Burning eCopies, Guidance Says

Devicemakers submitting eCopies with their submissions should double check their eCopy media before burning to make sure any preloaded files are removed, an FDA guidance update says. “Certain brands of media, particularly flash drives, come preloaded with files that may lead to your eCopy failing the loading process,” according to the Oct. 10 guidance released Thursday. These should be deleted before burning eCopies to the media, the guidance advises.
Devices & Diagnostics Letter