device that was the subject of the order. The hearing may also address the actions that might be required by a recall order, including an appropriate recall strategy, if FDA later orders a recall.

(c) If a request by the person named in a cease distribution and notification order for a regulatory hearing is granted, the regulatory hearing will be conducted in accordance with the procedures set out in section 201(x) of the act (21 U.S.C. 321(x)) and part 16 of this chapter, except that the order issued under §810.10, rather than a notice under § 16.22(a) of this chapter, provides the notice of opportunity for a hearing and is part of the administrative record of the regulatory hearing under §16.80(a) of this chapter. As provided in § 16.60(h) of this chapter, the Commissioner of Food and Drugs or presiding officer may waive, suspend, or modify any provision of part 16 under $10.19 of this chapter. As provided in §16.26(b), after the hearing commences, the presiding officer may issue a summary decision on any issue if the presiding officer determines that there is no genuine and substantial issue of fact respecting that issue.

(d) If the person named in the cease distribution and notification order does not request a regulatory hearing within the timeframe specified by FDA in the cease distribution and notification order, that person will be deemed to have waived his or her right to request a hearing.

(e) The presiding officer will ordinarily hold any regulatory hearing requested under paragraph (a) of this section no fewer than 2 working days after receipt of the request for a hearing, under $16.24(e) of this chapter, and no later than 10 working days after the date of issuance of the cease distribution and notification order. However, FDA and the person named in the order may agree to a later date or the presiding officer may determine that the hearing should be held in fewer than 2 days. Moreover, as provided for in § 16.60(h) of this chapter, the Commissioner of Food and Drugs or presiding officer may waive, suspend, or modify any provision of part 16 under § 10.19 of this chapter, including those pertaining to the timing of the hearing.

After the presiding officer prepares a written report of the hearing and the agency issues a final decision based on the report, the presiding officer shall provide the requestor written notification of the final decision to affirm, modify, or vacate the order or to amend the order to require a recall of the device within 15 working days of conducting a regulatory hearing.

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

(a) In lieu of requesting a regulatory hearing under § 810.11, the person

named in a cease distribution and notification order may submit a written request to FDA asking that the order be modified or vacated. Such person shall address the written request to the agency employee identified in the order and shall submit the request within the timeframe specified in the order, unless FDA and the person named in the order agree to a later date.

(b) A written request for review of a cease distribution and notification order shall identify each ground upon which the requestor relies in asking that the order be modified or vacated, as well as addressing an appropriate cease distribution and notification strategy, and shall address whether the order should be amended to require a recall of the device that was the subject of the order and the actions required by such a recall order, including an appropriate recall strategy.

(c) The agency official who issued the cease distribution and notification order shall provide the requestor written notification of the agency's decision to affirm, modify, or vacate the order or amend the order to require a recall of the device within 15 working days of receipt of the written request. The agency official shall include in this written notification:

(1) A statement of the grounds for the decision to affirm, modify, vacate, or amend the order; and

(2) The requirements of any modified or amended order.

§ 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 or completing agency review of a cease distribution and notification order under §810.12, 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, or within 15 working days of receipt of a written request for review of a cease distribution and notification order under § 810.12.

(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, and periodic reports describing the progress of the mandatory recall, as described in §810.16; 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) of the act.

8810.14 Cease distribution and notification or mandatory recall strategy.

(a) General. The person named in a cease distribution and notification order issued under § 810.10 shall comply with the order, which FDA will fashion as appropriate for the individual circumstances of the case. The person named in a cease distribution and notification order modified under §810.11(e) or $810.12(c) or a mandatory recall order issued under §810.13 shall develop a strategy for complying with the order that is appropriate for the individual circumstances and that takes into account the following factors:

(1) The nature of the serious, adverse health consequences related to the device;

(2) The ease of identifying the device; (3) The extent to which the risk presented by the device is obvious to a health professional or device user facility; and

(4) The extent to which the device is used by health professionals and device user facilities.

(b) Submission and review. (1) The person named in the cease distribution and notification order modified under § 810.11(e) or § 810.12(c) or mandatory recall order shall submit a copy of the proposed strategy to the agency within the timeframe specified in the order.

(2) The agency will review the proposed strategy and make any changes to the strategy that it deems necessary within 7 working days of receipt of the proposed strategy. The person named in the order shall act in accordance with a strategy determined by FDA to be appropriate.

(c) Elements of the strategy. A proposed strategy shall meet all of the following requirements:

(1)(i) The person named in the order shall specify the level in the chain of distribution to which the cease distribution and notification order or

mandatory recall order is to extend as follows:

(A) Consumer or user level, e.g., health professionals, consignee, or device user facility level, including any intermediate wholesale or retail level;

or

(B) Retail level, to the level immediately preceding the consumer or user level, and including any intermediate level; or

(C) Wholesale level.

(ii) The person named in the order shall not recall a device from individuals; and

(iii) The person named in the order shall not recall a device from device user facilities if FDA notifies the person not to do so because of a risk determination under § 810.13(c)(2).

(2) The person named in a recall order shall ensure that the strategy provides for notice to individuals subject to the risks associated with use of the recalled device. The notice may be provided through the individuals' health professionals if FDA determines that such consultation is appropriate and would be the most effective method of notifying patients.

(3) Effectiveness checks by the person named in the order are required to verify that all health professionals, device user facilities, consignees, and individuals, as appropriate, have been notified of the cease distribution and notification order or mandatory recall order and of the need to take appropriate action. The person named in the cease distribution and notification order or the mandatory recall order shall specify in the strategy the method(s) to be used in addition to written communications as required by §810.15, i.e., personal visits, telephone calls, or a combination thereof to contact all health professionals, device user facilities, consignees, and individuals, as appropriate. The agency may conduct additional audit checks where appropriate.

§810.15 Communications concerning a cease distribution and notification or mandatory recall order.

(a) General. The person named in a cease distribution and notification order issued under §810.10 or a mandatory recall order issued under § 810.13 is

responsible for promptly notifying each health professional, device user facility, consignee, or individual, as appropriate, of the order. In accordance with §810.10(c) or §810.13(b)(4), FDA may provide the person named in the cease distribution and notification or mandatory recall order with a model letter for notifying each health professional, device user facility, consignee, or individual, as appropriate, of the order. However, if FDA does not provide the person named in the cease distribution and notification or mandatory recall order with a model letter, the person named in a cease distribution and notification order issued under $810.10, or a mandatory recall order issued under §810.13, is responsible for providing such notification. The purpose of the communication is to convey:

(1) That FDA has found that there is a reasonable probability that use of the device would cause a serious, adverse health consequence or death;

(2) That the person named in the order has ceased distribution of the device;

(3) That health professionals and device user facilities should cease use of the device immediately;

(4) Where appropriate, that the device is subject to a mandatory recall order; and

(5) Specific instructions on should be done with the device.

what

(b) Implementation. The person named in a cease distribution and notification order, or a mandatory recall order, shall notify the appropriate person(s) of the order by verified written communication, e.g., telegram, mailgram, or fax. The written communication and any envelope in which it is sent or enclosed shall be conspicuously marked, preferably in bold red ink: "URGENT— [DEVICE CEASE DISTRIBUTION AND NOTIFICATION ORDER] or [MANDATORY DEVICE RECALL ORDER]." Telephone calls or other personal contacts may be made in addition to, but not as a substitute for, the verified written communication, and shall be documented in an appropriate manner.

(c) Contents. The person named in the order shall ensure that the notice of a cease distribution and notification order or mandatory recall order:

(1) Is brief and to the point;

(2) Identifies clearly the device, size, lot number(s), code(s), or serial number(s), and any other pertinent descriptive information to facilitate accurate and immediate identification of the device;

(3) Explains concisely the serious, adverse health consequences that may occur if use of the device were continued;

(4) Provides specific instructions on what should be done with the device;

(5) Provides a ready means for the recipient of the communication to confirm receipt of the communication and to notify the person named in the order of the actions taken in response to the communication. Such means may include, but are not limited to, the return of a postage-paid, self-addressed post card or a toll-free call to the person named in the order; and

(6) Does not contain irrelevant qualifications, promotional materials, or any other statement that may detract from the message.

(d) Followup communications. The person named in the cease distribution and notification order or mandatory recall order shall ensure that followup communications are sent to all who fail to respond to the initial communication.

(e) Responsibility of the recipient. Health professionals, device user facilities, and consignees who receive a communication concerning a cease distribution and notification order or a mandatory recall order should immediately follow the instructions set forth in the communication. Where appropriate, these recipients should immediately notify their consignees of the order in accordance with paragraphs (b) and (c) of this section.

§810.16 Cease distribution and notifi

cation or mandatory recall order status reports.

(a) The person named in a cease distribution and notification order issued under §810.10 or a mandatory recall order issued under §810.13 shall submit periodic status reports to FDA to enable the agency to assess the person's progress in complying with the order. The frequency of such reports and the agency official to whom such reports

shall be submitted will be specified in the order.

(b) Unless otherwise specified in the order, each status report shall contain the following information:

(1) The number and type of health professionals, device user facilities, consignees, or individuals notified about the order and the date and method of notification;

(2) The number and type of health professionals, device user facilities, consignees, or individuals who have responded to the communication and the quantity of the device on hand at these locations at the time they received the communication;

(3) The number and type of health professionals, device user facilities, consignees, or individuals who have not responded to the communication;

(4) The number of devices returned or corrected by each health professional, device user facility, consignee, or individual contacted, and the quantity of products accounted for;

(5) The number and results of effectiveness checks that have been made; and

(6) Estimated timeframes for completion of the requirements of the cease distribution and notification order or mandatory recall order.

(c) The person named in the cease distribution and notification order or recall order may discontinue the submission of status reports when the agency terminates the order in accordance with § 810.17.

§ 810.17 Termination of a cease dis tribution and notification or mandatory recall order.

(a) The person named in a cease distribution and notification order issued under §810.10 or a mandatory recall order issued under §810.13 may request termination of the order by submitting a written request to FDA. The person submitting a request shall certify that he or she has complied in full with all of the requirements of the order and shall include a copy of the most current status report submitted to the agency under § 810.16. A request for termination of a recall order shall include a description of the disposition of the recalled device.

(b) FDA may terminate a cease distribution and notification order issued under §810.10 or a mandatory recall order issued under §810.13 when the agency determines that the person named in the order:

(1) Has taken all reasonable efforts to ensure and to verify that all health professionals, device user facilities, consignees, and, where appropriate, individuals have been notified of the cease distribution and notification order, and to verify that they have been instructed to cease use of the device and to take other appropriate action; or

(2) Has removed the device from the market or has corrected the device so that use of the device would not cause serious, adverse health consequences or death.

(c) FDA will provide written notification to the person named in the order when a request for termination of a cease distribution and notification order or a mandatory recall order has been granted or denied. FDA will respond to a written request for termination of a cease distribution and notification or recall order within 30 working days of its receipt.

§810.18 Public notice.

The agency will make available to the public in the weekly FDA Enforcement Report a descriptive listing of each new mandatory recall issued under §810.13. The agency will delay public notification of orders when the agency determines that such notification may cause unnecessary and harmful anxiety in individuals and that initial consultation between individuals and their health professionals is essential.

812.19 Address for IDE correspondence. Subpart B-Application and Administrative Action

812.20 Application.

812.25 Investigational plan.

812.27 Report of prior investigations. 812.30 FDA action on applications. 812.35 Supplemental applications.

812.36 Treatment use of an investigational

device.

812.38 Confidentiality of data and information.

Subpart C-Responsibilities of Sponsors 812.40 General responsibilities of sponsors. FDA and IRB approval.

812.42 812.43 Selecting investigators and monitors. 812.45 Informing investigators. 812.46 Monitoring investigations.

812.47 Emergency research under $50.24 of this chapter.

Subpart D-IRB Review and Approval

812.60 IRB composition, duties, and functions.

812.62 IRB approval.

812.64 IRB's continuing review. 812.65 [Reserved]

812.66 Significant risk device determinations.

Subpart E-Responsibilities of Investigators 812.100 General responsibilities of investigators.

812.110 Specific responsibilities of investigators.

812.119 Disqualification of a clinical investigator.

Subpart F [Reserved]

Subpart G-Records and Reports

812.140 Records. 812.145 Inspections. 812.150 Reports.

AUTHORITY: 21 U.S.C. 331, 351, 352, 353, 355, 360, 360c-360f, 360h-360j, 371, 372, 374, 379e, 381, 382, 383; 42 U.S.C. 216, 241, 262, 263b-263n.

SOURCE: 45 FR 3751, Jan. 18, 1980, unless otherwise noted.

Subpart A-General Provisions §812.1 Scope.

(a) The purpose of this part is to encourage, to the extent consistent with the protection of public health and safety and with ethical standards, the discovery and development of useful