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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 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;
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. 8810.15 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;
(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 or 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
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.
(4) Where appropriate, that the device is subject to a mandatory recall order; and
(5) Specific instructions what should be done with the device.
(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
8 810.16 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, 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 8810.17.
8810.18 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.
Subpart A-General Provisions
Sec. 812.1 Scope. 812.2 Applicability. 812.3 Definitions. 812.5 Labeling of investigational devices. 812.7 Prohibition of promotion and other
practices. 812.10 Waivers. 812.18 Import and export requirements. 812.19 Address for IDE correspondence.
Subpart B-Application and Administrative
$ 810.17 Termination of a
cease distribution and notification or man
datory 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 mitting 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
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.
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 informa
Subpart C-Responsibilities of Sponsors 812.40 General responsibilities of sponsors. 812.42 FDA and IRB approval. 812.43 Selecting investigators and monitors. 812.45 Informing investigators. 812.46 Monitoring investigations. 812.47 Emergency research under $50.24 of
Subpart D-IRB Review and Approval
812.60 IRB composition, duties, and func
tions. 812.62 IRB approval. 812.64 IRB's continuing review. 812.65 [Reserved] 812.66 Significant risk device determina
Subpart E-Responsibilities of Investigators tion to comply with these require
ments under $ 812.20(b)(3) 812.100 General responsibilities of investiga
$812.140(b)(4)(v)) and color additive retors. 812.110 Specific responsibilities of investiga
quirements under section 721. tors.
(b) References in this part to regu812.119 Disqualification of a clinical investi- latory sections of the Code of Federal gator.
Regulations are to chapter I of title 21,
unless otherwise noted. Subpart F [Reserved]
[45 FR 3751, Jan. 18, 1980, as amended at 59 Subpart G-Records and Reports FR 14366, Mar. 28, 1994; 61 FR 52654, Oct. 7,
1996) 812.140 Records. 812.145 Inspections.
8812.2 Applicability. 812.150 Reports.
(a) General. This part applies to all AUTHORITY: 21 U.S.C. 331, 351, 352, 353, 355,
clinical investigations of devices to de360, 360c-360f, 360h-360j, 371, 372, 374, 379e, 381,
termine safety and effectiveness, ex382, 383; 42 U.S.C. 216, 241, 262, 263b-263n.
cept as provided in paragraph (c) of SOURCE: 45 FR 3751, Jan. 18, 1980, unless this section, otherwise noted.
(b) Abbreviated requirements. The fol
lowing categories of investigations are Subpart A-General Provisions
considered to have approved applica
tions for IDE's, unless FDA has noti8812.1 Scope.
fied a sponsor under $812.20(a) that ap(a) The purpose of this part is to en- proval of an application is required: courage, to the extent consistent with (1) An investigation of a device other the protection of public health and than a significant risk device, if the desafety and with ethical standards, the vice is not a banned device and the discovery and development of useful sponsor: devices intended for human use, and to (i) Labels the device in accordance that end to maintain optimum freedom with $812.5; for scientific investigators in their pur- (ii) Obtains IRB approval of the insuit of this purpose. This part provides vestigation after presenting the reprocedures for the conduct of clinical viewing IRB with a brief explanation of investigations of devices. An approved why the device is not a significant risk investigational device exemption (IDE) device, and maintains such approval; permits a device that otherwise would (iii) Ensures that each investigator be required to comply with a perform- participating in an investigation of the ance standard or to have premarket ap- device obtains from each subject under proval to be shipped lawfully for the the investigator's care, informed conpurpose of conducting investigations of sent under part 50 and documents it, that device. An IDE approved under unless documentation is waived by an $ 812.30 or considered approved under IRB under $ 56.109(c). 8812.2(b) exempts a device from the re- (iv) Complies with the requirements quirements of the following sections of of $812.46 with respect to monitoring the Federal Food, Drug, and Cosmetic investigations; Act (the act) and regulations issued (v) Maintains the records required thereunder: Misbranding under section under $812.140(b) (4) and (5) and makes 502 of the act, registration, listing, and the reports required under $812.150(b) premarket notification under section (1) through (3) and (5) through (10); 510, performance standards under sec- (vi) Ensures that participating investion 514, premarket approval under sec- tigators maintain the records required tion 515, a banned device regulation by 8812.140(a)(3)(i) and make the reunder section 516, records and reports ports required under $812.150(a) (1), (2), under section 519, restricted device re- (5), and (7); and quirements under section 520(e), good (vii) Complies with the prohibitions manufacturing practice requirements in $812.7 against promotion and other under section 520(f) except for the re- practices. quirements found in 8820.30, if applica- (2) An investigation of a device other ble (unless the sponsor states an inten- than one subject to paragraph (e) of
section, this part applies beginning on the date stipulated in an FDA regulation or order that calls for the submission of premarket approval applications for an unapproved class III device, or establishes a performance standard for a class II device.
(e) Investigations subject to IND's. A sponsor that, on July 16, 1980, has an effective investigational new drug application (IND) for an investigation of a device shall continue to comply with the requirements of part 312 until 90 days after that date. To continue the investigation after that date, a sponsor shall comply with paragraph (b)(1) of this section, if the device is not a significant risk device, or shall have obtained FDA approval under $812.30 of an IDE application for the investigation of the device. [45 FR 3751, Jan. 18, 1980, as amended at 46 FR 8956, Jan. 27, 1981; 46 FR 14340, Feb. 27, 1981; 53 FR 11252, Apr. 6, 1988; 62 FR 4165, Jan, 29, 1997; 62 FR 12096, Mar. 14, 1997)
this section, if the investigation was begun on or before July 16, 1980, and to be completed, and is completed, on or before January 19, 1981.
(c) Erempted investigations. This part, with the exception of 8812.119, does not apply to investigations of the following categories of devices:
(1) A device, other than a transitional device, in commercial distribution immediately before May 28, 1976, when used or investigated in accordance with the indications in labeling in effect at that time.
(2) A device, other than a transitional device, introduced into commercial distribution on or after May 28, 1976, that FDA has determined to be substantially equivalent to a device in commercial distribution immediately before May 28, 1976, and that is used or investigated in accordance with the indications in the labeling FDA reviewed under subpart E of part 807 in determining substantial equivalence.
(3) A diagnostic device, if the sponsor complies with applicable requirements in $ 809.10(c) and if the testing:
(i) Is noninvasive,
(ii) Does not require an invasive sampling procedure that presents significant risk,
(iii) Does not by design or intention introduce energy into a subject, and
(iv) Is not used as a diagnostic procedure without confirmation of the diagnosis by another, medically established diagnostic product or procedure.
(4) A device undergoing consumer preference testing, testing of a modification, or testing of a combination of two or more devices in commercial distribution, if the testing is not for the purpose of determining safety or effectiveness and does not put subjects at risk.
(5) A device intended solely for veterinary use.
(6) A device shipped solely for research on or with laboratory animals and labeled in accordance with 8812.5(c).
(7) A custom device as defined in $812.3(b), unless the device is being used to determine safety or effectiveness for commercial distribution.
(d) Limit on certain exemptions. In the case of class II or class III device described in paragraph (c)(1) or (2) of this
(a) Act means the Federal Food, Drug, and Cosmetic Act (sections 201901, 52 Stat. 1040 et seq., as amended (21 U.S.C. 301-392)).
(b) Custom device means a device that:
(1) Necessarily deviates from devices generally available or from an applicable performance standard or premarket approval requirement in order to comply with the order of an individual physician or dentist;
(2) Is not generally available to, or generally used by, other physicians or dentists;
(3) Is not generally available in finished form for purchase or for dispensing upon prescription;
(4) Is not offered for commercial distribution through labeling or advertising; and
(5) Is intended for use by an individual patient named in the order of a physician or dentist, and is to be made in a specific form for that patient, or is intended to meet the special needs of the physician or dentist in the course of professional practice.
(c) FDA means the Food and Drug Administration.
(d) Implant means a device that is placed into a surgically or naturally formed cavity of the human body if it