(c) Area inspection. Prior to the implementation of any labeling or packaging operation, there shall be an inspection of the area where the operation is to occur by a designated individual to assure that devices and labeling materials from prior operations do not remain in the labeling or packaging area. Any such items found shall be destroyed, disposed of, or returned to storage prior to the onset of a new or different labeling or packaging operation.

(d) Storage. Labels and labeling shall be stored and maintained in a manner that provides proper identification and is designed to prevent mixups.

(e) Labeling materials. Labeling materials issued for devices shall be examined for identity and, where applicable, the correct expiration date, control number, storage instructions, handling instructions, and additional processing instructions. A record of such examination, including the date and person performing the examination, shall be maintained in the device history record.

$820.121 Critical devices, device labeling.

In addition to the requirements of §820.120, the following requirements apply to critical devices:

(a) Control number. Labels issued for critical devices shall contain a control number.

(b) Labeling check. The signature of the individual who proofreads the labels and other labeling, and the date of the proofreading, shall be recorded.

(c) Access restriction. Access to the labels and other labeling shall be restricted to authorized personnel.

$820.130 Device packaging.

The device package and any shipping container for a device shall be designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution.

finished devices to assure that only those devices approved for release are distributed. Where a device's fitness for use or quality deteriorates over time, there shall be a system to assure that the oldest approved devices are distributed first.

$820.151 Critical devices, distribution records.

In addition to the requirements of §820.150, adequate distribution records for critical devices shall include, or make reference to the location of: the name and address of the consignee, the name and quantity of devices, the date shipped, and the control number used. These records shall be retained as required by § 820.180(b).

§ 820.152 Installation.

Where a device is installed by the manufacturer or its authorized representative, the manufacturer or representative shall inspect the device after installation to assure that the device will perform as intended. Where a device is installed by a person other than the manufacturer or its authorized representative, the manufacturer shall provide adequate instructions and procedures for proper installation.

Subpart 1-Device Evaluation

§ 820.160 Finished device inspection. There shall be written procedures for finished device inspection to assure that device specifications are met. Prior to release for distribution, each production run, lot or batch shall be checked and, where necessary, tested for conformance with device specifications. Where practical, a device shall be selected from a production run, lot or batch and tested under simulated use conditions. Sampling plans for checking, testing, and release of a device shall be based on an acceptable statistical rationale. Finished devices shall be held in quarantine or otherwise adequately controlled until released.

§ 820.161 Critical devices, finished device inspection.

In addition to the requirements of §820.160, the following requirement applies to critical devices: A critical de

vice or component which does not meet its performance specifications shall be investigated. A written record of the investigation, including conclusions and followup, shall be made. A critical device shall not leave the control of the manufacturer for distribution until all acceptance records and test results have been checked by a designated individual(s). Such individual(s) shall assure that all records and documentation required for the device history record are present and complete, and show that release of the device was consistent with the release criteria. Such individual(s) shall authorize, by signature, the release of the device for distribution.

$820.162 Failure investigation.

After a device has been released for distribution, any failure of that device or any of its components to meet performance specifications shall be investigated. A written record of the investigation, including conclusions and followup, shall be made.

Subpart J-Records

§820.180 General requirements.

All records required by this part shall be maintained at the manufacturing establishment or other location that is reasonably accessible to responsible officials of the manufacturer and to employees of the Food and Drug Administration designated to perform inspections. Such records shall be available for review and copying by such employees. Except as specifically provided elsewhere, the following general provisions shall apply to all records required by this part.

(a) Confidentiality. Those records deemed confidential by the manufacturer may be marked to aid the Food and Drug Administration in determining whether information may be disclosed under the public information regulation in Part 20 of this chapter.

(b) Record retention period. All required records pertaining to a device shall be retained for a period of time equivalent to the design and expected life of the device, but in no case less than 2 years from the date of release for commercial distribution by the manufacturer. Photostatic or other re

productions of records required by this part may be used.

§820.181 Device master record.

The device master record shall be prepared, dated, and signed by a designated individual(s). Any changes in the device master record shall be authorized in writing by the signature of a designated individual(s). Any approval forms shall be part of the device master record. The device master record for each type of device shall include, or refer to the location of, the following information:

(a) Device specifications including appropriate drawings, composition, formulation, and component specifications.

(b) Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications.

(c) Quality assurance procedures and specifications including quality assurance checks used and the quality assurance apparatus used.

(d) Packaging and labeling specifications including methods and processes used.

§ 820.182 Critical devices, device master record.

In addition to the requirements of § 820.181, the device master record for a critical device shall include or refer to the location of the following information:

(a) Critical components and critical component suppliers. Full information concerning critical components and critical component suppliers, including the complete specifications of all critical components, the sources where they may be obtained, and written copies of any agreements made with suppliers under § 820.81(b).

(b) Labels and labeling. Complete labeling procedures for the individual device and copies of all approved labels and other labeling.

§ 820.184 Device history record.

A device history record shall be maintained to demonstrate that the device is manufactured in accordance with the device master record. The device history record shall include, or

refer to the location of, the following information: The dates of manufacture, the quantity manufactured, the quantity released for distribution, and any control number used.

$820.185 Critical devices, device history record.

In addition to the requirements of $820.184, the following requirements apply to critical devices: There shall be a critical device history record for each control number, which shall include complete information relating to the production unit. This record shall identify the specific label, labeling, and control number used for each production unit and shall be readily accessible and maintained by a designated individual(s). The device history record shall include, or refer to the location of, the following:

(a) Component documentation. The documentation of each critical component used in the manufacture of a device shall include:

(1) Control number. The control number designating each critical component or lot of critical components used in the manufacture of a device.

(2) Acceptance record. The acceptance record of the critical component, including acceptance date and signature of the recipient.

(b) Record of critical operation. The record of, or reference to, each critical operation, identifying the date performed, the designated individual(s) performing the operation and, when appropriate, the major equipment used.

(c) Inspection checks. The inspection checks performed, the methods and equipment used, results, the date, and signature of the inspecting individual. $820.195 Critical devices, automated data processing.

viewed, evaluated, and maintained by a formally designated unit. This unit shall determine whether or not an investigation is necessary. When no investigation is made, the unit shall maintain a record that includes the reason and the name of the individual responsible for the decision not to investigate.

(b) Any complaint involving the possible failure of a device to meet any of its performance specifications shall be reviewed, evaluated, and investigated. Any complaint pertaining to injury, death, or any hazard to safety shall be immediately reviewed, evaluated, and investigated by a designated individual(s) and shall be maintained in a separate portion of the complaint file.

(c) When an investigation is made, a written record of each investigation shall be maintained by the formally designated unit identified in paragraph (a) of this section. The record of investigation shall include the name of the device, any control number used, name of complainant, nature of complaint, and reply to complainant.

(d) Where the formally designated unit is located at a site separate from the actual manufacturing establishment, a duplicate copy of the record of investigation of any complaint shall be transmitted to and maintained at the actual manufacturing establishment in a file designated for device complaints.

Subpart D-Records and Inspections

821.50 Availability. 821.55 Confidentiality.

821.60 Retention of records.

AUTHORITY: Secs. 301, 501, 502, 510, 515, 518, 519, 701, and 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331, 351, 352, 360, 360e, 360h, 3601, 371, and 374).

SOURCE: 58 FR 43447, Aug. 16, 1993, unless otherwise noted.

Subpart A-General Provisions

8821.1 Scope.

(a) The regulations in this part implement section 519(e) of the Federal Food, Drug, and Cosmetic Act (the act) which requires the adoption of a method of device tracking by any person who registers under section 510 of the act and is engaged in the manufacture and distribution of devices the failure of which would be reasonably likely to have serious adverse health consequences if the devices are life-sustaining or life-supporting devices used outside of a device user facility or are permanently implantable devices. This part also applies to any other device that the Food and Drug Administration (FDA) designates as requiring a method of tracking to protect the public health. A device subject to this part either by statutory requirement or by FDA designation is referred to herein as a "tracked device."

(b) These regulations are intended to ensure that tracked devices can be traced from the device manufacturing facility to the person for whom the device is indicated, that is, the patient. Effective tracking of devices from the manufacturing facility, through the distributor network (including distributors, retailers, rental firms and other commercial enterprises, device user facilities and licensed practitioners) and, ultimately, to any person for whom the device is intended is necessary for the effectiveness of remedies prescribed by the act, such as patient notification (section 518(a) of the act) or device recall (section 518(e) of the act). Although these regulations do not preclude a manufacturer from involving outside organizations in that manufacturer's device tracking effort, the legal responsibility for complying with

this part rests with manufacturers who must register under section 510 of the act, and that responsibility cannot be altered, modified, or in any way abrogated by contracts or other agreements.

(c) Each manufacturer of a tracked device shall implement a method of tracking devices by August 29, 1993.

(d) The primary burden for ensuring that the tracking system works rests upon the manufacturer. A manufacturer or any other person, including a distributor, final distributor, or multiple distributor, who distributes a device subject to tracking, who fails to comply with any applicable requirement of section 519(e) of the act or of this part, or any person who causes such failure, misbrands the device within the meaning of section 501(t)(2) of the act and commits a prohibited act within the meaning of sections 301(e) and 301(q)(1)(B) of the act.

(e) Any person subject to this part who permanently discontinues doing business is required to notify FDA at the time the person notifies any government agency, court, or supplier, and provide FDA with a complete set of its tracking records and information. However, if a person ceases distribution of a tracked device but continues to do other business, that person continues to be responsible for compliance with this part unless another person, affirmatively and in writing, assumes responsibility for continuing the tracking of devices previously distributed under this part. Further, if a person subject to this part goes out of business completely, but other persons acquire the right to manufacture or distribute tracked devices, those other persons are deemed to be responsible for continuing the tracking responsibility of the previous person under this part.

§ 821.2 Exemptions and variances.

(a) A manufacturer, importer, or distributor may seek an exemption or variance from one or more requirements of this part.

(b) A request for an exemption or variance shall be submitted in the form of a petition under §10.30 of this chapter and shall comply with the requirements set out therein, except that a re

sponse shall be issued in 90 days. The Director or Deputy Directors, CDRH, or the Director, Office of Compliance, CDRH, shall issue responses to requests under this section. The petition shall also contain the following:

(1) The name of the device and device class and representative labeling showing the intended use(s) of the device;

(2) The reasons that compliance with the tracking requirements of this part is unnecessary;

(3) A complete description of alternative steps that are available, or that the petitioner has already taken, to ensure that an effective tracking system is in place; and

(4) Other information justifying the exemption or variance.

(c) An exemption or variance is not effective until the Director, Office of Compliance and Surveillance, CDRH, approves the request under §10.30(e)(2)(i) of this chapter.

(d) For petitions received under this section before August 29, 1993, FDA will, within 60 days, approve or disapprove the petition or extend the effective date of this part for the device that is the subject of the petition. Any extension that FDA grants to the effective date will be based upon the additional time FDA needs to complete its review of the petition.

[58 FR 43447, Aug. 16, 1993, as amended at 59 FR 31138, June 17, 1994]

The following definitions and terms apply to this part:

(a) Act means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 321 et seq., as amended.

(b) Importer means the initial distributor of an imported device who is required to register under section 510 of the act and §807.20 of this chapter. "Importer" does not include anyone who only performs a service for the person who furthers the marketing, i.e., brokers, jobbers, or warehousers.

(c) Manufacturer means any person, including any importer, repacker and/ or relabeler, who manufactures, prepares, propagates, compounds, assembles, or processes a device or engages in any of the activities described in §807.3(d) of this chapter.

(d) Device failure means the failure of a device to perform or function as intended, including any deviations from the device's performance specifications or intended use.

(e) Serious adverse health consequences means any significant adverse experience related to a device, including device-related events which are lifethreatening or which involve permanent or long-term injuries or illnesses. (f) Permanently implantable device means a device that is intended to be placed into a surgically or naturally formed cavity of the human body to continuously assist, restore, or replace the function of an organ system or structure of the human body throughout the useful life of the device. The term does not include any device which is intended and used for temporary purposes or which is intended for explantation.

(g) Life-supporting or life-sustaining device used outside a device user facility means a device which is essential, or yields information that is essential, to the restoration or continuation of a bodily function important to the continuation of human life that is intended for use outside a hospital, nursing home, ambulatory surgical facility, or diagnostic or outpatient treatment facility. Physicians' offices are not device user facilities and, therefore, devices used therein are subject to tracking if they otherwise satisfy the statutory and regulatory criteria.

(h) Distributor means any person who furthers the distribution of a device from the original place of manufacture to the person who makes delivery or sale to the ultimate user, i.e., the final or multiple distributor, but who does not repackage or otherwise change the container, wrapper, or labeling of the device or device package.

(i) Final distributor means any person who distributes a tracked device intended for use by a single patient over the useful life of the device to the patient. This term includes, but is not limited to, licensed practitioners, retail pharmacies, hospitals, and other types of device user facilities.

(j) Distributes means any distribution of a tracked device, including the charitable distribution of a tracked device. This term does not include the dis