FDAnews Device Daily Bulletin

FDA WANTS DEVICE COMPANIES TO ISSUE RECALLS ELECTRONICALLY

May 22, 2006
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The FDA is encouraging device companies to use email and other forms of electronic communications such as fax or text messaging to announce voluntary recalls of FDA-regulated products and other important device safety information to the public.

All aspects of recall information can be handled through email or other electronic communication methods, the guidance indicates. Manufacturers can rely on other forms of communication if electronic follow-ups fail, the FDA says.

The guidance notes that electronic communications have a number of advantages over paper-based communications, such as shortening the time safety information becomes available to the public. Email and other electronic communication are cost effective and allow receipt or delivery to be automatically verified, the agency noted.

Moreover, email or other electronic communications are less likely to be discarded than traditional mail. For example, email systems set up in physicians' offices generally allow supplier communications to bypass spam filters.

The guidance offers more leeway in formatting of ecommunications recalls than it does for traditional paper recall letters, but recommends using methods such as marking an email message "Urgent." The communication should also not contain promotional material or links to other promotional materials, the guidance adds.

The complete guidance can be viewed at http://www.fda.gov/oc/guidance/electronic.html (http://www.fda.gov/oc/guidance/electronic.html).

(http://www.fdanews.com/ddl/33_20/)