Maps to
21 CFR Part 810: §810.10 Cease distribution and notification order., §810.11 Regulatory hearing., §810.12 Written request for review of cease distribution and notification order., §810.14 Cease distribution and notification or mandatory recall strategy., §810.15 Communications concerning a cease distribution and notification or mandatory recall order., §810.16 Cease distribution and notification or mandatory recall order status reports.
Requirement text
When FDA finds a reasonable probability that a device intended for human use would cause serious adverse health consequences or death, FDA may issue a cease distribution and notification order requiring the named person to immediately cease distribution of the device, notify health professionals and device user facilities of the order, and instruct them to cease use. If the order is modified under § 810.11(e) or § 810.12(c), or escalated to a mandatory recall order under § 810.13, the named person must develop and execute a strategy for complying with it that addresses the extent of notification, the need for public warnings, and the extent of effectiveness checks.
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