Maps to
21 CFR Part 810: §810.13 Mandatory recall order., §810.14 Cease distribution and notification or mandatory recall strategy., §810.16 Cease distribution and notification or mandatory recall order status reports., §810.17 Termination of a cease distribution and notification or mandatory recall order.
Requirement text
If FDA issues a mandatory recall order, the named person must submit a proposed recall strategy to FDA addressing the level in the distribution chain to which the recall extends, notification requirements, public warning needs, and effectiveness check methods. The strategy must be submitted within the timeframe specified in the order, is subject to FDA review and modification within 7 working days, and must address notification to individuals subject to risks associated with the recalled device. Periodic status reports must be submitted showing notification progress, device returns, and estimated completion timeframes.
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