---
kind: "section"
citation: "21 C.F.R. § 810.13"
title: "21"
number: "810.13"
heading: "Mandatory recall order."
url: "https://uscodex.org/cfr/21/810.13"
---

# §810.13. Mandatory recall order.

- (a) If the person named in a cease distribution and notification order does not request a regulatory hearing or submit a request for agency review of the order, or, if the Commissioner of Food and Drugs or the presiding officer denies a request for a hearing, or, if after conducting a regulatory hearing under [§ 810.11](/cfr/21/810.11.md) or completing agency review of a cease distribution and notification order under [§ 810.12](/cfr/21/810.12.md), FDA determines that the order should be amended to require a recall of the device with respect to which the order was issued, FDA shall amend the order to require such a recall. FDA shall amend the order to require such a recall within 15 working days of issuance of a cease distribution and notification order if a regulatory hearing or agency review of the order is not requested, or within 15 working days of denying a request for a hearing, or within 15 working days of completing a regulatory hearing under [§ 810.11](/cfr/21/810.11.md), or within 15 working days of receipt of a written request for review of a cease distribution and notification order under [§ 810.12](/cfr/21/810.12.md).
- (b) **In a mandatory recall order, FDA may—**
  - (1) Specify that the recall is to extend to the wholesale, retail, or user level;
  - (2) Specify a timetable in accordance with which the recall is to begin and be completed;
  - (3) Require the person named in the order to submit to the agency a proposed recall strategy, as described in [§ 810.14](/cfr/21/810.14.md), and periodic reports describing the progress of the mandatory recall, as described in [§ 810.16](/cfr/21/810.16.md); and
  - (4) Provide the person named in the order with a model recall notification letter that includes the key elements of information that FDA has determined are necessary to inform health professionals and device user facilities.
- (c) FDA will not include in a mandatory recall order a requirement for:
  - (1) Recall of a device from individuals; or
  - (2) Recall of a device from device user facilities, if FDA determines that the risk of recalling the device from the facilities presents a greater health risk than the health risk of not recalling the device from use, unless the device can be replaced immediately with an equivalent device.
- (d) FDA will include in a mandatory recall order provisions for notification to individuals subject to the risks associated with use of the device. If a significant number of such individuals cannot be identified, FDA may notify such individuals under [section 705(b)](/cfr/21/705.md?p=b) of the act.

## Notes

### Authority

Authority: 21 U.S.C. 321, 331, 332, 333, 334, 351, 352, 355, 360h, 360i, 371, 374, 375.

### Source

Source: 61 FR 59018, Nov. 20, 1996, unless otherwise noted.