required to comply with all requirements of this part applicable to manufacturers. Importers must keep all information required under this part in the United States.

Subpart B-Tracking Requirements $821.20 Devices subject to tracking.

(a) A manufacturer of any device the failure of which would be reasonably likely to have a serious adverse health consequence, that is either a life-sustaining or life-supporting device used outside of a device user facility or a permanently implantable device, or a manufacturer of any other device that FDA, in its discretion, designates for tracking, shall track that device in accordance with this part.

(b) Manufacturers have the responsibility to identify devices that meet the criteria for tracking and to initiate tracking. By way of illustration and to provide guidance, FDA has set out below a list of example devices it regards as subject to tracking under the criteria set forth in this regulation. (1) Permanently implantable devices.

(d) FDA, when responding to premarket notification submissions and approving premarket approval applications, will notify the sponsor that FDA believes the device meets the criteria of section 519(e)(1) and therefore should be tracked. FDA will also, after notifying the sponsor, publish a notice in the FEDERAL REGISTER announcing that FDA believes a new generic type of device is subject to tracking and soliciting comment on FDA's position. If the device is a new generic type of device not already on the example list above, FDA will add it to this list.

[58 FR 43447, Aug. 16, 1993, as amended at 58 FR 43455, Aug. 16, 1993; 59 FR 15052, Mar. 31, 1994.]

§ 821.25 Device tracking system and content requirements: manufacturer requirements.

(a) A manufacturer of a tracked device shall adopt a method of tracking for each such type of device that it distributes that enables a manufacturer to provide FDA with the following information in writing for each tracked device distributed:

(1) Except as required by order under section 518(e) of the act, within 3 working days of a request from FDA, prior to the distribution of a tracked device to a patient, the name, address, and telephone number of the distributor, multiple distributor, or final distributor holding the device for distribution and the location of the device;

(2) Within 10 working days of a request from FDA for life-sustaining or life-supporting devices used outside a device user facility that are intended for use by a single patient over the life of the device and permanent implants that are tracked devices, after distribution to or implantation in a patient:

(i) The lot number, batch number, model number, or serial number of the

device or other identifier necessary to provide for effective tracking of the devices;

(ii) The date the device was shipped by the manufacturer;

(iii) The name, address, telephone number, and social security number (if available) of the patient receiving the device;

(iv) The date the device was provided to the patient;

(v) The name, mailing address, and telephone number of the prescribing physician;

(vi) The name, mailing address, and telephone number of the physician regularly following the patient if different than the prescribing physician; and

(vii) If applicable, the date the device was explanted and the name, mailing address, and telephone number of the explanting physician; the date of the patient's death; or the date the device was returned to the manufacturer, permanently retired from use, or otherwise permanently disposed of.

(3) Except as required by order under section 518(e) within 10 working days of a request from FDA for life-sustaining or life-supporting devices used outside device user facilities that are intended for use by more than one patient and that are tracked devices, after the distribution of the device to the multiple distributor:

(i) The lot model number, batch number, serial number of the device or other identifier necessary to provide for effective tracking of the device;

(ii) The date the device was shipped by the manufacturer;

(iii) The name, address, and telephone number of the multiple distributor;

(iv) The name, address, telephone number, and social security number (if available) of the patient using the device;

(v) The location of the device;

(vi) The date the device was provided for use by the patient;

(vii) The name, address, and telephone number of the prescribing physician; and

(viii) If and when applicable, the date the device was returned to the manufacturer, permanently retired from use, or otherwise permanently disposed of.

(b) A manufacturer of a tracked device shall keep current records in accordance with its standard operating procedure of the information identified in paragraphs (a)(1), (a)(2) and (a)(3)(i) through (a)(3)(iii) of this section on each tracked device released for distribution for as long as such device is in use or in distribution for use.

(c) A manufacturer of a tracked device shall establish a written standard operating procedure for the collection, maintenance, and auditing of the data specified in paragraphs (a) and (b) of this section. A manufacturer shall make this standard operating procedure available to FDA upon request. A manufacturer shall incorporate the following into the standard operating procedure:

(1) Data collection and recording procedures, which shall include a procedure for recording when data which is required under this part is missing and could not be collected and the reason why such required data is missing and could not be collected;

(2) A method for recording all modifications or changes to the tracking system or to the data collected and maintained under the tracking system, reasons for any modification or change, and dates of any modification or change. Modification and changes included under this requirement include modifications to the data (including termination of tracking), the data format, the recording system, and the file maintenance procedures system; and

(3) A quality assurance program that includes an audit procedure to be run for each device product subject to tracking, at not less than 6-month intervals for the first 3 years of distribution and at least once a year thereafter. This audit procedure shall provide for statistically relevant sampling of the data collected to ensure the accuracy of data and performance testing of the functioning of the tracking system.

(d) When a manufacturer becomes aware that a distributor, final distributor, or multiple distributor has not collected, maintained, or furnished any record or information required by this part, the manufacturer shall notify the FDA district office responsible for the area in which the distributor,

final distributor, or multiple distributor is located of the failure of such persons to comply with the requirements of this part. Manufacturers shall have taken reasonable steps to obtain compliance by the distributor, multiple distributor, or final distributor in question before notifying FDA.

(e) A manufacturer may petition for an exemption or variance from one or more requirements of this part according to the procedures in §821.2 of this chapter.

Subpart C-Additional Requirements and Responsibilities

$821.30 Tracking obligations of persons other than device manufacturers: distributor requirements.

(a) A distributor, final distributor, or multiple distributor of any tracked device shall, upon purchasing or otherwise acquiring any interest in such a device, promptly provide the manufacturer tracking the device with the following information:

(1) The name and address of the distributor, final distributor or multiple distributor;

(2) The lot number, batch number, model number, or serial number of the device or other identifier used by the manufacturer to track the device;

(3) The date the device was received; (4) The person from whom the device was received;

(5) If and when applicable, the date the device was explanted, the date of the patient's death, or the date the device was returned to the distributor, permanently retired from use, or otherwise permanently disposed of.

(b) A final distributor, upon sale or other distribution of a tracked device for use in or by the patient, shall promptly provide the manufacturer tracking the device with the following information:

(1) The name and address of the final distributor,

(2) The lot number, batch number, model number, or serial number of the device or other identifier used by the manufacturer to track the device;

(3) The name, address, telephone number, and social security number (if

available) of the patient receiving the device;

(4) The date the device was provided to the patient or for use in the patient; (5) The name, mailing address, and telephone number of the prescribing physician;

(6) The name, mailing address, and telephone number of the physician regularly following the patient if different than the prescribing physician; and

(7) When applicable, the date the device was explanted and the name, mailing address, and telephone number of the explanting physician, the date of the patient's death, or the date the device was returned to the manufacturer, permanently retired from use, or otherwise permanently disposed of.

(c)(1) A multiple distributor shall keep written records of the following each time such device is distributed for use by a patient:

(i) The lot number, batch number, or model number, or serial number of the device or other identifier used by the manufacturer to track the device;

(ii) The name, address, telephone number, and social security number (if available) of the patient using the device;

(iii) The location of the device;

(iv) The date the device was provided for use by the patient;

(v) The name, address, and telephone number of the prescribing physician;

(vi) The name, address, and telephone number of the physician regularly following the patient if different than the prescribing physician; and

(vii) When applicable, the date the device was permanently retired from use or otherwise permanently disposed of.

(2) Except as required by order under section 518(e) of the act, any person who is a multiple distributor subject to the recordkeeping requirement of paragraph (c)(1) of this section shall, within 5 working days of a request from the manufacturer or within 10 working days of a request from FDA for the information identified in paragraph (c)(1) of this section, provide such information to the manufacturer or FDA.

(d) A distributor, final distributor, or multiple distributor shall make any records required to be kept under this part available to the manufacturer of

the tracked device for audit upon written request by an authorized representative of the manufacturer.

(e) A distributor, final distributor, or multiple distributor may petition for an exemption or variance from one or more requirements of this part according to the procedures in § 821.2.

Subpart D-Records and
Inspections

§ 821.50 Availability.

(a) Manufacturers, distributors, multiple distributors, and final distributors shall, upon the presentation by an FDA representative of official credentials and the issuance of Form FD 482 at the initiation of an inspection of an establishment or person under section 704 of the act, make each record and all information required to be collected and maintained under this part and all records and information related to the events and persons identified in such records available to FDA personnel.

(b) Records and information referenced in paragraph (a) of this section shall be available to FDA personnel for purposes of reviewing, copying, or any other use related to the enforcement of the act and this part. Records required to be kept by this part shall be kept in a centralized point for each manufacturer or distributor within the United States.

§821.55 Confidentiality.

(a) Records and other information submitted to FDA under this part shall be protected from public disclosure to the extent permitted under part 20 of this chapter, and in accordance with § 20.63 of this chapter, information contained in such records that would identify patient or research subjects shall not be available for public disclosure except as provided in those parts.

(b) Patient names or other identifiers may be disclosed to a manufacturer or other person subject to this part or to a physician when the health or safety of the patient requires that such persons have access to the information. Such notification will be pursuant to agreement that the record or information will not be further disclosed except as the health aspects of the patient requires. Such notification does

not constitute public disclosure and will not trigger the availability of the same information to the public generally.

§821.60 Retention of records.

Persons required to maintain records under this part shall maintain such records for the useful life of each tracked device they manufacture or distribute. The useful life of a device is the time a device is in use or in distribution for use. For example, a record may be retired if the person maintaining the record becomes aware of the fact that the device is no longer in use, has been explanted, returned to the manufacturer, or the patient has died.

860.123 Reclassification petition: Content and form.

860.125 Consultation with panels. 860.130 General procedures under section 513(e) of the act.

860.132 Procedures when the Commissioner initiates a performance standard or premarket approval proceeding under section 514(b) or 515(b) of the act.

860.134 Procedures for "new devices" under section 513(f) of the act and reclassification of certain devices.

860.136 Procedures for transitional products under section 520(1) of the act.

AUTHORITY: 21 U.S.C. 360c, 360d, 360e, 360i, 360j, 371, 374.

SOURCE: 43 FR 32993, July 28, 1978, unless otherwise noted.

Subpart A-General

§860.1 Scope.

for

(a) This part implements sections 513, 514(b), 515(b), and 520(1) of the act with respect to the classification and reclasof devices intended sification human use. (b) This part prescribes the criteria and procedures to be used by classification panels in making their recommendations and by the Commissioner in making the Commissioner's determinations regarding the class of regulatory control (class I, class II, or class III) appropriate for particular devices. Supplementing the general Food and Drug Administration procedures governing advisory committees (part 14 of this chapter), this part also provides procedures for manufacturers, importers, and other interested persons to participate in proceedings to classify and reclassify devices. This part also describes the kind of data required for determination of the safety and effectiveness of a device, and the circumstances under which information submitted to classification panels or to the Commissioner in connection with classification and reclassification proceedings will be available to the public. §860.3 Definitions.

For the purposes of this part:

(a) Act means the Federal Food, Drug, and Cosmetic Act.

(b) Commissioner means the Commissioner of Food and Drugs, Food and Drug Administration, United States Department of Health and Human Services, or the Commissioner's designee.

(c) Class means one of the three categories of regulatory control for medical devices, defined below:

(1) Class I means the class of devices that are subject to only the general controls authorized by or under sections 501 (adulteration), 502 (misbranding), 510 (registration), 516 (banned devices), 518 (notification and other remedies), 519 (records and reports), and 520 (general provisions) of the act. A device is in class I if (i) general controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device, or (ii) there is insufficient information from which

to determine that general controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device or to establish special controls to provide such assurance, but the device is not life-supporting or life-sustaining or for a use which is of substanial importance in preventing impairment of human health, and which does not present a potential unreasonable risk of illness of injury.

(2) Class II means the class of devices that is or eventually will be subject to special controls. A device is in class II if general controls alone are insufficient to provide reasonable assurance of its safety and effectiveness and there is sufficient information to establish special controls, including the promulgation of performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines (including guidelines for the submission of clinical data in premarket notification submissions in accordance with section 510(k) of the act), recommendations, and other appropriate actions as the Commissioner deems necessary to provide such assurance. For a device that is purported or represented to be for use in supporting or sustaining human life, the Commissioner shall examine and identify the special controls, if any, that are necessary to provide adequate assurance of safety and effectiveness and describe how such controls provide such assur

ance.

(3) Class III means the class of devices for which premarket approval is or will be required in accordance with section 515 of the act. A device is in class III if insufficient information exists to determine that general controls are sufficient to provide reasonable assurance of its safety and effectiveness or that application of special controls described in paragraph (c)(2) of this section would provide such assurance and if, in addition, the device is life-supporting or life-sustaining, or for a use which is of substantial importance in preventing impairment of human health, or if the device presents a potential unreasonable risk of illness or injury.

(d) Implant means a device that is placed into a surgically or naturally