Documentation Helps Devicemakers Avoid ‘Silent Recall’ Warnings

Devicemakers making routine software updates to installed products should document the intent of those updates to avoid being cited by the FDA for failure to report a recall. So-called “silent” or “secret” recalls are “a hot issue right now with the agency,” Michael Barile, founder of consulting company Barile & Associates, said during an FDAnews webinar. Such recalls involve taking a field action to address a health risk without informing the FDA.
Devices & Diagnostics Letter