not previously submitted as part of the PMA:

(i) Unpublished reports of data from any clinical investigations or nonclinical laboratory studies involving the device or related devices and known to or that reasonably should be known to the applicant.

(ii) Reports in the scientific literature concerning the device and known to or that reasonably should be known to the applicant. If, after reviewing the summary and bibliography, FDA concludes that the agency needs a copy of the unpublished or published reports, FDA will notify the applicant that copies of such reports shall be submitted.

(Approved by the Office of Management and Budget under control number 09100231)

[51 FR 26364, July 22, 1986, as amended at 51 FR 43344, Dec. 2, 1986]

Subpart J-Records

820.180 General requirements. 820.181 Device master record.

820.182 Critical devices, device master record.

820.184 Device history record.

820.185 Critical devices, device history record.

820.195 Critical devices, automated data processing.

820.198 Complaint files.

AUTHORITY: Secs. 501, 502, 515, 518, 519, 520, 701, 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351, 352, 360e, 360h, 360i, 360j, 371, 374).

SOURCE: 43 FR 31508, July 21, 1978, unless otherwise noted.

Subpart A-General Provisions

§ 820.1 Scope.

The regulation set forth in this part describes current good manufacturing practices for methods used in, and the facilities and controls used for, the manufacture, packing, storage, and installation of all finished devices intended for human use. The regulation is intended to assure that such devices will be safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act. Part 820 establishes basic requirements applicable to finished devices, including additional requirements for critical de

vices. This regulation is not intended to apply to manufacturers of components or parts of finished devices, but such manufacturers are encouraged to use appropriate provisions of this regulation as guidelines. Manufacturers of human blood and blood components are not subject to this part, but are subject to Part 606 of this chapter.

(a) Authority. This Part 820 is established and promulgated under authority of sections 501, 502, 518, 519, 520(f), and 701(a) of the act (21 U.S.C. 351, 352, 360h, 360i, 360j(f), and 371(a)). The failure to comply with any applicable provisions in Part 820 in the manufacture, packing, storage, or installation of a device renders the device adulterated under section 501(h) of the act. Such a device, as well as the person responsible for the failure to comply, is subject to regulatory action.

(b) Limitations. The current good manufacturing practice regulation in Part 820 supplements regulations in other parts of this chapter except where explicitly stated otherwise. In the event it is impossible to comply with applicable regulations both in this part and in other parts of this chapter, the regulations specifically applicable to the device in question shall supersede any other regulations.

(c) Applicability. The provisions of Part 820 shall be applicable to any finished device, as defined in this part, intended for human use, that is manufactured, imported, or offered for import in any State or territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.

(d) Exemptions or variances. Any person who wishes to petition for an exemption or variance from any device good manufacturing practice requirement is subject to the requirements of section 520(f)(2) of the act. Petitions for an exemption or variance shall be submitted according to the procedures set forth in § 10.30 of this chapter, the Food and Drug Administration's administrative procedures. Guidance is available from the Center for Devices and Radiological Health, Division of Compliance Programs, Manufacturing Quality Assurance Branch (HFZ-332),

1390 Piccard Dr., Rockville, MD 20850; telephone 301-427-1128.

[43 FR 31508, July 21, 1978, as amended at 44 FR 75628, Dec. 21, 1979; 53 FR 11253, Apr. 6, 1988; 55 FR 11169, Mar. 27, 1990)

§ 820.3 Definitions.

(a) Act means the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201-902, 52 Stat. 1040 et seq., as amended (21 U.S.C. 321-392)).

(b) Audit means a documented activity performed in accordance with written procedures on a periodic basis to verify, by examination and evaluation of objective evidence, compliance with those elements of the quality assurance program under review. "Audit" does not include surveillance or inspection activities performed for the purpose of conducting a quality assurance program or undertaking complaint investigations or failure analyses of a device.

(c) Component means any material, substance, piece, part, or assembly used during device manufacture which is intended to be included in the finished device.

(d) Control number means any distinctive combination of letters or numbers, or both, from which the complete history of the manufacture, control, packaging, and distribution of a production run, lot, or batch of finished devices can be determined.

(e) Critical component means any component of a critical device whose failure to perform can be reasonably expected to cause the failure of a critical device or to affect its safety or effectiveness.

(f) Critical device means a device that is intended for surgical implant into the body or to support or sustain life and whose failure to perform when properly used in accordance with instructions for use provided in the labeling can be reasonably expected to result in a significant injury to the user. Critical devices will be identified by the Commissioner after consultation with the Device Good Manufacturing Practice Advisory Committee authorized under section 520(f) of the act, and an illustrative list of critical devices will be available from the Center for Devices and Radiological

Health, Food and Drug Administration.

(g) Critical operation means any operation in the manufacture of a critical device which, if improperly performed, can be reasonably expected to cause the failure of a critical device or to affect its safety or effectiveness.

(h) Device history record means a compilation of records containing the complete production history of a finished device.

(i) Device master record means a compilation of records containing the design, formulation, specifications, complete manufacturing procedures, quality assurance requirements, and labeling of a finished device.

(j) Finished device means a device, or any accessory to a device, which is suitable for use, whether or not packaged or labeled for commercial distribution.

(k) Manufacturer means any person, including any repacker and/or relabeler, who manufactures, fabricates, assembles, or processes a finished device. The term does not include any person who only distributes a finished device.

(1) Manufacturing material means any material such as a cleaning agent, mold-release agent, lubricating oil, or other substance used to facilitate a manufacturing process and which is not intended by the manufacturer to be included in the finished device.

(m) Noncritical device means any finished device other than a critical device.

(n) Quality assurance means all activities necessary to assure and verify confidence in the quality of the process used to manufacture a finished device.

[43 FR 31508, July 21, 1978, as amended at 53 FR 11253, Apr. 6, 1988]

§ 820.5 Quality assurance program.

Every finished device manufacturer shall prepare and implement a quality assurance program that is appropriate to the specific device manufactured and meets the requirements of this part.

Subpart B-Organization and Personnel

§ 820.20 Organization.

Each manufacturer shall have in place an adequate organizational structure and sufficient personnel to assure that the devices the manufacturer produces are manufactured in accordance with the requirements of this regulation. Each manufacturer shall prepare and implement quality assurance procedures adequate to assure that a formally established and documented quality assurance program is performed. Where possible, a designated individual(s) not having direct responsibility for the performance of a manufacturing operation shall be responsible for the quality assurance program.

(a) Quality assurance program requirements. The quality assurance program shall consist of procedures adequate to assure that the following functions are performed:

(1) Review of production records;

(2) Approval or rejection of all components, manufacturing materials, inprocess materials, packaging materials, labeling, and finished devices; approval or rejection of devices manufactured, processed, packaged, or held under contract by another company;

(3) Identifying, recommending, or providing solutions for quality assurance problems and verifying the implementation of such solutions; and

(4) Assuring that all quality assurance checks are appropriate and adequate for their purpose and are performed correctly.

(b) Audit procedures. Planned and periodic audits of the quality assurance program shall be implemented to verify compliance with the quality assurance program. The audits shall be performed in accordance with written procedures by appropriately trained individuals not having direct responsibilities for the matters being audited. Audit results shall be documented in written audit reports, which shall be reviewed by management having responsibility for the matters audited. Followup corrective action, including reaudit of deficient matters, shall be taken when indicated. An employee of

chanical, automated, or electronic equipment, shall be suitable for its intended purposes and shall be capable of producing valid results. Such equipment shall be routinely calibrated, inspected, and checked according to written procedures. Records documenting these activities shall be maintained. When computers are used as part of an automated production or quality assurance system, the computer software programs shall be validated by adequate and documented testing. All program changes shall be made by a designated individual(s) through a formal approval procedure.

(a) Calibration. Calibration procedures shall include specific directions and limits for accuracy and precision. There shall be provisions for remedial action when accuracy and precision limits are not met. Calibration shall be performed by personnel having the necessary education, training, background, and experience.

(b) Calibration standards. Where practical, the calibration standards used for production and quality assurance measurement equipment shall be traceable to the national standards of the National Bureau of Standards, Department of Commerce. If national standards are not practical for the parameter being measured, an independent reproducible standard shall be used. If no applicable standard exists, an in-house standard shall be developed and used.

(c) Calibration records. The calibration date, the calibrator, and the next calibration date shall be recorded and displayed, or records containing such information shall be readily available for each piece of equipment requiring calibration. A designated individual(s) shall maintain a record of calibration dates and of the individual performing each calibration.

Subpart E-Control of Components § 820.80 Components.

Components used in manufacturing shall be received, stored, and handled in a manner designed to prevent damage, mixup, contamination, and other adverse effects. Components shall be quarantined prior to accept