2005D-0385 Guidance for Industry on Using Electronic Means to Distribute Certain Product Information
FDA Comment Number : EC2
Submitter : Mr. Gregory Bobrowicz Date & Time: 11/01/2005 05:11:24
Organization : FDAReady Consulting
Category : Individual Consumer
Issue Areas/Comments
Line 52 of the guidance states that if receipt is not acknowledged, "the sender can resort to more traditional methods of notification." Once this is stated, though, the rest of the guidance provides no recommendation or requirement for this follow up. Using the agency's new definition of "can" in line 129, the entire meaning of the guidance seemingly allows ineffective recall communication. The recalling firm "can" use more traditional methods. Or they "can" use others, such as repeating the ineffective email.

If a firm emails a recall notification that is hung on spam filters (or it is simply unread), receipt would not be acknowledged, and a company would be required to do nothing. The guidance must not allow this. Email is fast and cheap, but it is inherently less reliable than certified mail.

Recalls are often life and death situations. The guidance should be clear that:
(a) Electronic notification requires read-confirmation of the message
(b) When the recalling firm fails to receive read-confirmation within a short time, perhaps 5 calendar days, the recalling firm must send the "more traditional methods of notification" currently required in 21 CFR 7.49 and 200.5.