District of Columbia Administrative Code

10702 MANAGEMENT RESPONSIBILITY 10702.1 Management with executive responsibility shall establish its policy and objectives for, and commitment to, quality. Management with executive responsibility shall ensure that the quality policy is understood, implemented, and maintained at …

10703 QUALITY AUDIT: TRAINED PERSONNEL 10703.1 Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the qua…

10704 RESERVED SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10704 AUTHORITY: DC-DCMR Section 19(a)(3) of the District of Columbia Pharmacist and Pharmacy Regulation Act of 198…

10705 DESIGN CONTROLS 10705.1 Each manufacturer of any class III or class II device, and the class I devices listed in § 10705.2, shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met. 10705.2 The…

10706 DOCUMENT CONTROLS 10706.1 Each manufacturer shall establish and maintain procedures to control all documents that are required by this chapter. 10706.2 Each manufacturer shall designate an individual(s) to review for adequacy and approve prior to issuance all documents esta…

10707 PURCHASING CONTROLS 10707.1 Each manufacturer shall establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements. 10707.2 Each manufacturer shall establish and maintain the requirements, includin…

10708 IDENTIFICATION 10708.1 Each manufacturer shall establish and maintain procedures for identifying products during all stages of receipt, production, distribution, and installation to prevent mix-ups. SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). Distric…

10709 TRACEABILITY 10709.1 Each manufacturer of 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 t…

10710 PRODUCTION AND PROCESS CONTROLS 10710.1 Each manufacturer shall develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications. Where deviations from device specifications could occur as a result of the manufacturing proce…

10711 INSPECTION, MEASURING, AND TEST EQUIPMENT 10711.1 Each manufacturer shall ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of produci…

10712 PROCESS VALIDATION 10712.1 Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures. The validation activities and results, incl…

10713 RECEIVING, IN-PROCESS, AND FINISHED DEVICE ACCEPTANCE 10713.1 Each manufacturer shall establish and maintain procedures for acceptance activities. Acceptance activities include inspections, tests, or other verification activities. 10713.2 Each manufacturer shall establish a…

10714 ACCEPTANCE STATUS 10714.1 Each manufacturer shall identify by suitable means the acceptance status of the product, to indicate the conformance or nonconformance of the product with acceptance criteria. The identification of acceptance status shall be maintained throughout m…

10715 NON-CONFORMING PRODUCT 10715.1 Each manufacturer shall establish and maintain procedures to control products that do not conform to specified requirements. The procedures shall address the identification, documentation, evaluation, segregation, and disposition of nonconform…

10716 CORRECTIVE AND PREVENTIVE ACTION 10716.1 Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action. The procedures shall include requirements for: Analyzing processes, work operations, concessions, quality audit reports, qua…

10717 DEVICE LABELING 10717.1 Each manufacturer shall establish and maintain procedures to control labeling activities. 10717.2 Labels shall be printed and applied so as to remain legible and affixed during the customary conditions of processing, storage, handling, distribution, …

10718 DEVICE PACKAGING 10718.1 Each manufacturer shall ensure that device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution. SOURCE: Fin…

10719 HANDLING 10719.1 Each manufacturer shall establish and maintain procedures to ensure that mix-ups, damage, deterioration, contamination, or other adverse effects to products do not occur during handling. SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). Di…

10720 STORAGE 10720.1 Each manufacturer shall establish and maintain procedures for the control of storage areas and stock rooms for product to prevent mix-ups, damage, deterioration, contamination, or other adverse effects pending use or distribution and to ensure that no obsole…

10721 DISTRIBUTION 10721.1 Each manufacturer shall establish and maintain procedures for control and distribution of finished devices to ensure that only those devices approved for release are distributed and that purchase orders are reviewed to ensure that ambiguities and errors…

10722 INSTALLATION 10722.1 Each manufacturer of a device requiring installation shall establish and maintain adequate installation and inspection instructions, and where appropriate test procedures. Instructions and procedures shall include directions for ensuring proper installa…

10723 GENERAL REQUIREMENTS 10723.1 All records required by this chapter 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 Department designated to perform ins…

10724 DEVICE MASTER RECORD 10724.1 Each manufacturer shall maintain device master records (DMR). Each manufacturer shall ensure that each DMR is prepared and approved in accordance with § 10706. The DMR for each type of device shall include, or refer to the location of, the follo…

10725 DEVICE HISTORY RECORD 10725.1 Each manufacturer shall maintain Device History Records (DHRs). Each manufacturer shall establish and maintain procedures to ensure that DHRs for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordan…

10726 QUALITY SYSTEM RECORD 10726.1 Each manufacturer shall maintain a quality system record (QSR). The QSR shall include, or refer to the location of, procedures and the documentation of activities required by this chapter that are not specific to a particular type of device(s),…

10727 COMPLAINT FILES 10727.1 Each manufacturer shall maintain complaint files. Each manufacturer shall establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. Such procedures shall ensure that: All complaints are proce…

10728 SERVICING 10728.1 Where servicing is a specified requirement, each manufacturer shall establish and maintain instructions and procedures for performing and verifying that the servicing meets the specified requirements. 10728.2 Each manufacturer shall analyze service reports…

10729 STATISTICAL TECHNIQUES 10729.1 Where appropriate, each manufacturer shall establish and maintain procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics…

10799 DEFINITIONS 10799.1 As used in this chapter, the following terms shall have the meanings ascribed: Act – the Federal Food, Drug, and Cosmetic Act, approved June 25, 1938 (21 U.S.C. § 301, et seq.) Complaint - any written, electronic, or oral communication that alleges defic…

10800 EXAMPLES OF ELECTRONIC PRODUCTS SUBJECT TO THE RADIATION CONTROL FOR HEALTH AND SAFETY ACT OF 1968 10800.1 The following listed electronic products are intended to serve as illustrative examples of sources of electronic product radiation to which these regulations apply: Ex…

10801 RECOMMENDATIONS FOR THE USE OF SPECIFIC AREA GONAD SHIELDING ON PATIENTS DURING MEDICAL DIAGNOSIS X-RAY PROCEDURES 10801.1 Specific area gonad shielding covers an area slightly larger than the region of the gonads. It may therefore be used without interfering with the objec…

10802 RECOMMENDATION FOR QUALITY ASSURANCE PROGRAMS IN DIAGNOSTIC RADIOLOGY FACILITIES 10802.1 Quality assurance programs are recommended for all diagnostic radiology facilities. 10802.2 A quality assurance program should contain the elements listed in § 10802.3 through 10802.23.…

10803 RECOMMENDATION ON ADMINISTRATIVELY REQUIRED DENTAL X-RAY EXAMINATIONS 10803.1 The Department recommends that dental x‑ray examinations be performed only after careful consideration of the dental or other health needs of the patient, that is, when the patient's dentist or ph…

10804 APPLICABILITY 10804.1 The provisions of this chapter are applicable as follows: All manufacturers of electronic products are subject to § 10815; Manufacturers, dealers, and distributors of electronic products are subject to the provisions set forth in table 1 of this sectio…

10805 NOTIFICATION TO USER OF PERFORMANCE AND TECHNICAL DATA 10805.1 The Director and Deputy Director of the Center for Devices and Radiological Health, as authorized under delegated authority, may require a manufacturer of a radiation emitting electronic product to provide to th…

10806 CONFIDENTIALITY OF INFORMATION 10806.1 The Secretary or his or her representative shall not disclose any information reported to or otherwise obtained by him or her, pursuant to this chapter, which concerns or relates to a trade secret or other matter referred to in Section…

10807 SUBMISSION OF DATA AND REPORTS 10807.1 All submissions such as reports, test data, product descriptions, and other information required by this chapter, or voluntarily submitted to the Department, shall be filed with the number of copies prescribed by the Department and sha…

10808 PRODUCT REPORTS 10808.1 Every manufacturer of a product or component requiring a product report as set forth in Table 1 of § 10804 shall submit a product report to the Department, prior to the introduction of such product into commerce. The report shall be distinctly marked…

10809 SUPPLEMENTAL REPORTS 10809.1 Prior to the introduction into commerce of a new or modified model within a model or chassis family of a product listed in Table 1 of § 10804 for which a report under § 10808 is required, each manufacturer shall submit a report with respect to s…

10810 ABBREVIATED REPORTS 10810.1 Manufacturers of products requiring abbreviated reports as specified in Table 1 of § 10804 shall submit, prior to the introduction of such product, a report distinctly marked "Radiation Safety Abbreviated Report" which shall include: (a) Firm and…

10811 ANNUAL REPORTS 10811.1 Every manufacturer of products requiring an annual report as specified in Table 1 of § 10804 shall submit an annual report summarizing the contents of the records required to be maintained by § 10816.1 and providing the volume of products produced, so…

10812 RECORDS TO BE OBTAINED BY DEALERS AND DISTRUBUTORS 10812.1 Dealers and distributors of electronic products for which there are performance standards and for which the retail price is fifty dollars ($50) or more shall obtain such information as is necessary to identify and l…

10813 DISPOSITION OF RECORDS OBTAINED BY DEALERS AND DISTRIBUTORS 10813.1 Information obtained by dealers and distributors pursuant to § 10812 shall immediately be forwarded to the appropriate manufacturer unless: The dealer or distributor elects to hold and preserve such informa…

10814 CONFIDENTIALITY OF RECORDS FURNISHED BY DEALERS AND DISTRIBUTORS 10814.1 All information furnished to manufacturers by dealers and distributors pursuant to this chapter shall be treated by such manufacturers as confidential information which may be used only as necessary to…

10815 REPORTING OF ACCIDENTAL RADIATION OCCURRENCES 10815.1 Manufacturers of electronic products shall, where reasonable grounds for suspecting that such an incident has occurred, immediately report to the Department all accidental radiation occurrences reported to or otherwise k…

10816 RECORDS TO BE MAINTAINED BY MANUFACTURERS 10816.1 Manufacturers of products listed under Table 1 of § 10804 shall establish and maintain the following records with respect to such products: Description of the quality control procedures with respect to electronic product rad…

10817 PRESERVATION AND INSPECTION OF RECORDS 10817.1 Every manufacturer required to maintain records pursuant to this part, including records received pursuant to § 10813, shall preserve such records for a period of five (5) years from the date of the record. 10817.2 Upon reasona…

10818 SPECIAL EXEMPTIONS 10818.1 Manufacturers of electronic products may submit to the Director a request, together with accompanying justification, for exemption from any requirements listed in Table 1 of § 10804. The request must specify each requirement from which an exemptio…

10819 EXEMPTIONS FOR MANUFACTURERS OF PRODUCTS INTENDED FOR THE DISTRICT OF COLUMBIA 10819.1 Upon application therefore by the manufacturer, the Department may exempt from the provisions of this chapter a manufacturer of any electronic product intended for use by departments or a…

10820 APPLICABILITY 10820.1 The provisions of this chapter are applicable to electronic products which were manufactured after October 18, 1968. SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medici…