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
After providing the appropriate person with an opportunity to consult with the agency, if FDA finds that there is 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 person named in the order to immediately cease distribution of the device, notify health professionals and device user facilities of the order, and instruct these professionals and device user facilities to cease use of the device. 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.