District of Columbia Administrative Code

10821 DEFECT IN ELECTRONIC PRODUCTS 10821.1 For the purpose of this chapter, an electronic product shall be considered to have a defect which relates to the safety of use by reason of the emission of electronic product radiation if: (a) It is a product which does not utilize the …

10822 EFFECT OF REGULATION ON OTHER LAWS 10822.1 The remedies provided for in this chapter shall be in addition to and not in substitution for any other remedies provided by law and shall not relieve any person from liability at common law or under statutory law. SOURCE: Final Ru…

10823 DISCOVERY OF DEFECT OR FAILURE OF COMPLIANCE BY MANUFACTURER – NOTICE REQUIREMENTS 10823.1 Any manufacturer who discovers that any electronic product produced, assembled, or imported by him or her, which product has left its place of manufacture, has a defect or fails to co…

10824 DETERMINATION BY THE DEPARTMENT OF HEALTH THAT PRODUCT FAILS TO COMPLY OR HAS A DEFECT 10824.1 If, the Department through testing, inspection, research, or examination of reports or other data, determines that any electronic product does not comply with an applicable standa…

10825 NOTIFICATION BY THE MANUFACTURER TO THE DEPARTMENT OF HEALTH 10825.1 The notification to the Department required by § 10823.1(a) shall be confirmed in writing and, in addition to other relevant information which the Department may require, shall include the following: Ident…

10826 NOTIFICATION BY THE MANUFACTURER TO AFFECTED PERSONS 10826.1 The notification to the persons specified in § 10823.1(b) shall be in writing and, in addition to other relevant information which the Department may require, shall include: The information prescribed by § 10825.1…

10827 COPIES OF COMMUNICATIONS SENT TO PURCHASERS, DEALERS, OR DISTRIBUTORS 10827.1 Every manufacturer of electronic products shall furnish to the Department a copy of all notices, bulletins, or other communications sent to the dealers or distributors of such manufacturers or to …

10828 APPLICATION FOR EXEMPTION FROM NOTIFICATION REQUIREMENTS 10828.1 A manufacturer may at the time of giving the written confirmation required by § 10825 or within fifteen (15) days of the receipt of any notice from the Secretary pursuant to § 10824.1(a), apply for an exemptio…

10829 GRANTING THE EXEMPTION 10829.1 If, in the judgment of the Department, the application filed pursuant to § 10828 states reasonable grounds for an exemption from the requirement of notice, the Department shall give the manufacturer written notice specifying a reasonable perio…

10830 MANUFACTURER’S OBLIGATION TO REPAIR, REPLACE, OR REFUND COST OF ELECTRONIC PRODUCTS 10830.1 If any electronic product fails to comply with an applicable District standard or has a defect and the notification specified in § 10823.1(b) is required to be furnished, the manufac…

10831 PLANS FOR THE REPAIR OF ELECTRONIC PRODUCTS 10831.1 Every plan for bringing an electronic product into conformity with applicable District standards or for remedying any defect in such product shall be submitted to the Department in writing, and in addition to other relevan…

10832 PLANS FOR THE REPLACEMENT OF ELECTRONIC PRODUCTS 10832.1 Every plan for replacing an electronic product with a like or equivalent product shall be submitted to the Department in writing, and in addition to other relevant information which the Department may require, shall i…

10833 PLANS FOR REFUNDING THE COST OF ELECTRONIC PRODUCTS 10833.1 Every plan for refunding the cost of an electronic product shall be submitted to the Department in writing, and in addition to other relevant information which the Department may require, shall include: Identificat…

10834 APPROVAL OF PLAN 10834.1 If, after review of any plan submitted pursuant to this chapter, the Department determines that the action to be taken by the manufacturer will expeditiously and effectively fulfill the manufacturer's obligation under § 10830 in a manner designed to…

10844 SCOPE 10844.1 The standards listed in this chapter are applicable to electronic products as specified herein, to control electronic product radiation from such products. Standards so prescribed are subject to amendment or revocation and additional standards may be prescribe…

10845 CERTIFICATION 10845.1 Every manufacturer of an electronic product for which an applicable standard is in effect under this chapter shall furnish to the dealer or distributor, at the time of delivery of such product, the certification that such product conforms to all applic…

10846 IDENTIFICATION 10846.1 Every manufacturer of an electronic product to which a standard under this chapter is applicable shall set forth the information specified in § 10846.2 and § 10846.3. This information shall be provided in the form of a tag or label permanently affixed…

10847 VARIANCES 10847.1 Upon application by a manufacturer (including an assembler), the Department may grant a variance from one (1) or more provisions of any performance standard for an electronic product subject to such standard when the Director determines that granting such …

10848 EXEMPTIONS FOR PRODUCTS INTENDED FOR UNITED STATES GOVERNMENT USE 10848.1 Upon application by a manufacturer (including the assembler), the Department may grant an exemption from any performance standard for an electronic product, or class of products, otherwise subject to …

10849 SPECIAL TEST PROCEDURE 10849.1 The Department may, on the basis of a written application by a manufacturer, authorize test programs other than those set forth in the standards under this chapter for an electronic product if he or she determines that such products are not su…

10850 ELECTRONIC PRODUCTS INTENDED FOR EXPORT 10850.1 The performance standards prescribed in this chapter shall not apply to any electronic product which is intended solely for export if: Such product and the outside of any shipping container used in the export of such product a…

10851 TELEVISION RECEIVERS 10851.1 The provisions of this section are applicable to television receivers manufactured subsequent to January 15, 1970. 10851.2 Radiation exposure rates produced by a television receiver shall not exceed one half milliroentgens per hour (0.5 mR/hr.) …

10852 COLD-CATHODE GAS DISCHARGE TUBES 10852.1 The provisions of this section are applicable to cold-cathode gas discharge tubes designed to demonstrate the effects of a flow of electrons or the production of x-radiation as specified herein. 10852.2 Radiation exposure rates produ…

10853 DIAGNOSTIC X-RAY SYSTEMS AND THEIR MAJOR COMPONENTS 10853.1 The provisions of this section are applicable to: The following components of diagnostic x‑ray systems: (1) Tube housing assemblies, x‑ray controls, x‑ray high-voltage generators, x‑ray tables, cradles, film change…

10854 RADIOGRAPHIC EQUIPMENT 10854.1 The provisions of this section apply to equipment for radiography, except equipment for fluoroscopic imaging or for recording images from the fluoroscopic image receptor, or computed tomography x‑ray systems manufactured on or after November 2…

10855 FLUOROSCOPIC EQUIPMENT 10855.1 The provisions of this section apply to equipment for fluoroscopic imaging or for recording images from the fluoroscopic image receptor, except computed tomography x‑ray systems manufactured on or after November 29, 1984. 10855.2 The fluorosco…

10856 HIGH INTENSITY MERCURY VAPOR DISCHARGE LAMPS 10856.1 The provisions of this section apply to any high-intensity mercury vapor discharge lamp that is designed, intended, or promoted for illumination purposes and is manufactured or assembled after March 7,1980, except as desc…

10857 ULTRASONIC THERAPY PRODUCTS 10857.1 The provisions of this section are applicable as specified herein to any ultrasonic therapy product for use in physical therapy manufactured on or after February 17, 1979. 10857.2 As used in this section the following definitions apply: A…

10899 DEFINITIONS 10899.1 As used in this chapter, the following terms shall have the meanings ascribed: Accidental radiation occurrence - a single event or series of events that has/have resulted in injurious or potentially injurious exposure of any person to electronic product …

10900 SCOPE 10900.1 The purpose of this chapter is to encourage, to the extent consistent with the protection of public health and safety and with ethical standards, the discovery and development of useful devices intended for human use, and to that end to maintain optimum freedo…

10901 APPLICABILITY 10901.1 This chapter applies to all clinical investigations of devices to determine safety and effectiveness, except as provided in § 10901.3. 10901.2 The following categories of investigations are considered to have approved applications for IDE unless the De…

10902 LABELING OF INVESTIGATIONAL DEVICES 10902.1 An investigational device or its immediate package shall bear a label with the following information: the name and place of business of the manufacturer, packer, or distributor (in accordance with § 10300), the quantity of content…

10903 PROHIBITION OF PROMOTION AND OTHER PRACTICES 10903.1 A sponsor, investigator, or any person acting for or on behalf of a sponsor or investigator shall not: (a) Promote or test market an investigational device, until after the Department has approved the device for commercia…

10904 WAIVERS 10904.1 A sponsor may request the Department to waive any requirement of this section. A waiver request, with supporting documentation, may be submitted separately or as part of an application to the address in § 10906. 10904.2 The Department may, by letter, grant a…

10905 IMPORT AND EXPORT REQUIREMENTS 10905.1 In addition to complying with other requirements of this part, a person who imports or offers for importation an investigational device subject to this part shall be the agent of the foreign exporter with respect to investigations of t…

10906 ADDRESS FOR INVESTIGATIONAL DEVICE EXEMPTION CORRESPONDENCE 10906.1 If you are sending an application, supplemental application, report, request for waiver, request for import or export approval, or other correspondence relating to matters covered by this part, you must add…

10907 APPLICATION 10907.1 A sponsor: (a) Shall submit an application to the Department if the sponsor intends to use a significant risk device in an investigation, intends to conduct an investigation that involves an exception from informed consent under § 10602.6, or if DOH noti…

10908 INVESTIGATIONAL PLAN 10908.1 The investigational plan shall include, in the following order: (a) The name and intended use of the device and the objectives and duration of the investigation; (b) A written protocol describing the methodology to be used and an analysis of the…

10909 REPORT OF PRIOR INVESTIGATIONS 10909.1 The report of prior investigations shall include reports of all prior clinical, animal, and laboratory testing of the device and shall be comprehensive and adequate to justify the proposed investigation. 10909.2 The report also shall i…

10910 DEPARTMENT OF HEALTH ACTION ON APPLICATIONS 10910.1 The Department will notify the sponsor in writing of the date it receives an application. DOH may approve an investigation as proposed, approve it with modifications, or disapprove it. An investigation may not begin until:…

10911 SUPPLEMENTAL APPLICATIONS 10911.1 The following are required for changes the in investigational plan: (a) Except as described in Paragraphs (b) through (d), a sponsor must obtain approval of a supplemental application under § 10910.1, and IRB approval when appropriate (see …

10912 TREATMENT USE OF AN INVESTIGATIONAL DEVICE 10912.1 A device that is not approved for marketing may be under clinical investigation for a serious or immediately life-threatening disease or condition in patients for whom no comparable or satisfactory alternative device or oth…

10913 CONFIDENTIALITY OF DATA AND INFORMATION 10913.1 The Department will not disclose the existence of an IDE unless its existence has previously been publicly disclosed or acknowledged, until DOH approves an application for premarket approval of the device subject to the IDE; o…

10914 GENERAL RESPONSIBILITIES OF SPONSORS 10914.1 Sponsors are responsible for selecting qualified investigators and providing them with the information they need to conduct the investigation properly, ensuring proper monitoring of the investigation, ensuring that IRB review and…

10915 DEPARTMENT OF HEALTH AND INSTITUTIONAL REVIEW BOARD APPROVAL 10915.1 A sponsor shall not begin an investigation or part of an investigation until an IRB and the Department have both approved the application or supplemental application relating to the investigation or part o…

10916 SELECTING INVESTIGATORS AND MONITORS 10916.1 A sponsor shall select investigators qualified by training and experience to investigate the device. 10916.2 A sponsor shall ship investigational devices only to qualified investigators participating in the investigation. 10916.3…

10917 INFORMING INVESTIGATORS 10917.1 A sponsor shall supply all investigators participating in the investigation with copies of the investigational plan and the report of prior investigations of the device. SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). Dist…

10918 MONITORING INVESTIGATIONS 10918.1 A sponsor who discovers that an investigator is not complying with the signed agreement, the investigational plan, the requirements of this part or other applicable Department regulations, or any conditions of approval imposed by the review…

10919 EMERGENCY RESEARCH 10919.1 A sponsor shall monitor the progress of all investigations involving an exception from informed consent under 21 C.F.R., part 50. When the sponsor receives from the IRB information concerning the public disclosures under 21 C.F.R. § 50.24(a)(7)(ii…

10920 INSTITUTIONAL REVIEW BOARD COMPOSITION, DUTIES, AND FUNCTIONS 10920.1 An IRB reviewing and approving investigations under 21 C.F.R., part 56 shall comply with the requirements in these regulations in all respects, including its composition, duties, and functions. SOURCE: Fi…