FDA 21 CFR Part 810 Medical Device Recall Authority

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Table of contents

Subpart A - General Provisions

810.1 Scope.

810.2 Definitions.

810.3 Computation of time.

810.4 Service of orders.

Subpart B - Mandatory Medical Device Recall Procedures

810.10 Cease distribution and notification order.

810.11 Regulatory hearing.

810.12 Written request for review of cease distribution and notification order.

810.13 Mandatory recall 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.

810.17 Termination of a cease distribution and notification or mandatory recall order.

810.18 Public notice.

FDA 21 CFR Part 810 Medical Device Recall Authority: