forms to its original design or any approved changes in that design.

(a) Specification controls. (1) Procedures for specification control measures shall be established to assure that the design basis for the device, components, and packaging is correctly translated into approved specifications.

(2) Specification changes shall be subject to controls as stringent as those applied to the original design specifications of the device. Such changes shall be approved and documented by a designated individual(s) and shall include the approval date and the date the change becomes effective.

(b) Processing controls. (1) Where deviations from device specifications could occur as a result of the manufacturing process itself, there shall be written procedures describing any processing controls necessary to assure conformance to specifications.

(2) All processing control operations shall be conducted in a manner designed to assure that the device conforms to applicable specifications.

(3) There shall be a formal approval procedure for any change in the manufacturing process of a device. Any approved change shall be communicated to appropriate personnel in a timely

manner.

§ 820.101 Critical devices, manufacturing specifications, and processes.

In addition to the requirements of § 820.100, the following requirements apply to critical devices:

(a) Critical operation performance. Any critical operation shall be performed by a suitable designated individual(s) or suitable equipment and shall be verified.

(b) Record of critical operation. Any individual responsible for the performance of a critical operation shall record or reference that operation in the device history record as required in § 820.185.

§ 820.115 Reprocessing of devices or components.

(a) Reprocessing procedures shall be established, implemented, and controlled to assure that the reprocessed device or component meets the origi

nal, or subsequently modified and approved, specifications.

(b) Any device rejected during finished device inspection and later reprocessed shall be subject to another complete final inspection for any characteristic of the device which may be adversely affected by such reprocessing.

§ 820.116 Critical devices, reprocessing of devices or components.

In addition to the requirements of § 820.115, the following requirements apply to critical devices:

(a) Reprocessing procedures. There shall be written procedures for any reprocessing associated with the production of a critical device or component. These procedures shall prescribe the equipment to be used in reprocessing and shall include any special quality assurance methods or tests. The procedures shall be designed so that the reprocessed device or component meets the original, or subsequently modified and approved, specifications. The procedures shall be designed to prevent adulteration, e.g., because of material, structural, or molecular change in the device or component due to reprocessing. Special care shall be taken to assure that the device or component to be reprocessed is clearly identified and separated from like devices or components not to be reprocessed. When there is constant reprocessing of a device or component, a determination of the effect of the reprocessing upon the device or component shall be made and documented. There shall be a formal approval procedure for instituting a new, or altering an approved, reprocessing procedure.

(b) Reprocessing control. Any critical device or component subject to reprocessing procedures shall conform to the original, or subsequently modified and approved, specifications. Written testing and sampling procedures to assure such comformity shall be contained or referenced in the device master record. Any prior quality assurance check shall be repeated on the reprocessed device or component if the reprocessing could adversely affect any performance characteristic previously inspected.

Subpart G-Packaging and Labeling Control

§ 820.120 Device labeling.

There shall be adequate controls to ~maintain labeling integrity and to prevent labeling mixups.

(a) Label integrity. Labels shall be designed, printed, and applied so as to remain legible during the customary conditions of processing, storage, handling, distribution, and use. Labels and other labeling shall not be released to "inventory until a designated individual has proofread samples of the labeling for accuracy.

(b) Separation of operations. Each labeling or packaging operation shall be separated physically or spatially in a manner designed to prevent mixups.

(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

§ 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 I-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 device 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 reproductions 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 assur

ance 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 Iwith 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.

§ 820.198 Complaint files.

(a) Written and oral complaints relative to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device shall be reviewed, 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

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

AUTHORITY: Secs. 513, 514, 515, 519, 520, 701, 704 of the Federal Food, Drug, and Cosmetic Act (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.

(a) This part implements sections 513, 514(b), 515(b), and 520(1) of the act with respect to the classification and reclassification of devices intended for 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.

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)