District of Columbia Administrative Code

10314 DEVICES FOR PROCESSING, REPACKING, OR MANUFACTURING 10314.1 A device intended for processing, repacking, or use in the manufacture of another drug or device shall be exempt if its label bears the statement "Caution: For manufacturing, processing, or repacking." SOURCE: Fina…

10315 MEDICAL DEVICES FOR USE IN TEACHING, LAW ENFORCEMENT, RESEARCH, AND ANALYSIS 10315.1 A device subject to § 10310 of this chapter shall be exempt from 21 U.S.C. § 352(f)(1) if shipped or sold to, or in the possession of, persons regularly and lawfully engaged in instruction …

10316 MEDICAL DEVICES: EXPIRATION OF EXEMPTIONS 10316.1 If a shipment or delivery, or any part thereof, of a device which is exempt under the regulations in this section is made to a person in whose possession the article is not exempt, or is made for any purpose other than those…

10317 OTHER EXEMPTIONS - MEDICAL DEVICES: PROCESSING, LABELING, OR REPACKING 10317.1 Except as provided by §§ 10317.2 and 10317.3, a shipment or other delivery of a device which is, in accordance with the practice of the trade, to be processed, labeled, or repacked, in substantia…

10318 SPECIAL REQUIREMENTS FOR SPECIFIC DEVICES - LABELING OF ARTICLES INTENDED FOR LAY USE IN THE REPAIRING OR REFITTING OF DENTURES 10318.1 The American Dental Association and leading dental authorities have advised the FDA of their concern regarding the safety of denture relin…

10319 USE OF IMPACT-RESISTANT LENSES IN EYEGLASSES AND SUNGLASSES 10319.1 Examination of data available on the frequency of eye injuries resulting from the shattering of ordinary crown glass lenses indicates that the use of such lenses constitutes an avoidable hazard to the eye o…

10320 MAXIMUM ACCEPTABLE LEVEL OF OZONE 10320.1 Ozone is a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy. In order for ozone to be effective as a germicide, it must be present in a concentration far greater than that which can b…

10321 CHLOROFLUOROCARBON PROPELLANTS 10321.1 The use of chlorofluorocarbon in devices as propellants in self-pressurized containers is generally prohibited except as provided in 21 C.F.R. § 2.125. SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Col…

10322 HEARING AID DEVICES: PROFESSIONAL AND PATIENT LABELING 10322.1 Hearing aids shall be clearly and permanently marked with: (a) The name of the manufacturer or distributor, the model name or number, the serial number, and the year of manufacture; and (b) A "+" symbol to indic…

10323 HEARING AID DEVICES: CONDITIONS FOR SALE 10323.1 Except as provided in § 10323.2, a hearing aid dispenser shall not sell a hearing aid unless the prospective user has presented to the hearing aid dispenser a written statement signed by a licensed physician that states that …

10324 USER LABELING FOR MENSTRUAL TAMPON 10324.1 This section applies to scented or scented deodorized menstrual tampons as identified in 21 C.F.R. § 884.5460 and unscented menstrual tampons as identified in 21 C.F.R. § 884.5470. 10324.2 Data show that Toxic Shock Syndrome (TSS),…

10325 WARNING STATEMENTS FOR PRESCRIPTION AND RESTRICTED DEVICE PRODUCTS CONTAINING OR MANUFACTURED WITH CHLOROFLUOROCARBONS OR OTHER OZONE-DEPLETING SUBSTANCES 10325.1 All prescription and restricted device products containing or manufactured with chlorofluorocarbons, halons, ca…

10326 USER LABELING FOR LATEX CONDOMS 10326.1 This section applies to the subset of condoms as identified in 21 C.F.R. § 884.5300, and condoms with spermicidal lubricant identified in 21 C.F.R. § 884.5310, whose products are formed from latex films. 10326.2 Data show that the mat…

10327 USER LABELING FOR DEVICES THAT CONTAIN NATURAL RUBBER 10327.1 Data in the Medical Device Reporting System and the scientific literature indicate that some individuals are at risk of severe anaphylactic reactions to natural latex proteins. This labeling regulation is intende…

10399 DEFINITIONS 10399.1 As used in this chapter, the following terms and phrases shall have the meanings ascribed: Adequate directions for use - directions under which the layman can use a device safely and for the purposes for which it is intended. Directions for use may be in…

10400 GENERAL 10400.1 This section establishes the requirements for medical device reporting for device user facilities, manufacturers, importers, and distributors. A device user facility shall report deaths and serious injuries that a device has or may have caused or contributed…

10401 PUBLIC AVAILABILITY OF REPORTS 10401.1 The Department may disclose to the public any report, including any record of a telephone report, submitted under this part. 10401.2 Before the Department discloses a report to the public, the Department shall delete the following: (a)…

10402 GENERAL DESCRIPTION OF REPORTS REQUIRED FROM USER FACILITIES, IMPORTERS, AND MANUFACTURERS 10402.1 A device user facility must submit the following reports: (a) Reports of individual adverse events no later than ten (10) work days after the day that the facility becomes awa…

10403 RESERVED SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10403 AUTHORITY: DC-DCMR Section 19(a)(3) of the District of Columbia Pharmacist and Pharmacy Regulation Act of 198…

10404 WHERE TO SUBMIT REPORTS 10404.1 You must submit any written report or additional information required under this part to the DC Department of Health, 899 North Capitol Street, N.E., 2nd Floor, Washington, D.C. 20002. 10404.2 You must specifically identify each report (for e…

10405 ENGLISH REPORTING REQUIREMENT 10405.1 All written or electronic equivalent reports must be in English. SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10405 AUTHORITY: DC-D…

10406 ELECTRONIC REPORTING 10406.1 You may electronically submit any report required by this part if you have our prior written consent. We may revoke this consent at anytime. Electronic report submissions include alternative reporting media (magnetic tape, and disc) and computer…

10407 REQUESTS FOR ADDITIONAL INFORMATION 10407.1 The Department will notify you in writing if we require additional information and will tell you what information we need. The Department will require additional information if the Department determines that protection of the publ…

10408 DISCLAIMERS 10408.1 A report or other information submitted by you, and the Department’s release of report or information, is not necessarily an admission that the device, or you or your employees, caused or contributed to the reportable event. You do not have to admit and …

10409 WRITTEN MEDICAL DEVICE REPORT PROCEDURES 10409.1 If you are a user facility, importer, or manufacturer, you must develop, maintain, and implement written MDR procedures for the following: (a) Internal systems that provide for: (1) Timely and effective identification, commun…

10410 FILES AND DISTRIBUTOR RECORDS 10410.1 A user facility, importer, or manufacturer shall establish and maintain MDR event files. The user shall clearly identify all MDR event files, and maintain them to facilitate timely access. 10410.2 For purposes of this section, "MDR even…

10411 EXEMPTIONS, VARIANCES, AND ALTERNATIVE REPORTING REQUIREMENTS 10411.1 The following persons are exempt from the adverse event reporting requirements of this section: (a) A licensed practitioner who prescribes or administers devices intended for use in humans and manufacture…

10412 HOW TO REPORT ADVERSE EVENTS 10412.1 If you are a user facility, you must submit MDR reports to: (a) The manufacturer and to the Department no later than ten (10) business days after the day that you become aware of information that reasonably suggests that a device has or …

10413 WHERE TO FIND REPORTING CODES USED WITH MEDICAL DEVICE REPORTS 10413.1 The Department shall publish adverse events on its website. 10413.2 The Department may sometimes use additional coding of information on the reporting forms or modify the existing codes. If the Departmen…

10414 WHEN NOT TO FILE A REPORT 10414.1 If you become aware of information from multiple sources regarding the same patient and same reportable event, you may submit one (1) medical device report. 10414.2 You are not required to submit a medical device report if: (a) You are a us…

10415 INDIVIDUAL ADVERSE EVENT REPORTS: USER FACILITIES 10415.1 If you are a user facility, you must submit reports to the manufacturer or to the Department or both, as specified below: (a) When reporting a death, you must submit a report to the Department as soon as practicable …

10416 INDIVIDUAL ADVERSE EVENT REPORT DATA ELEMENTS FOR USER FACILITIES 10416.1 A user facility shall include the following information in its report, if reasonably known: (a) For patient information, the user facility shall submit the following: (1) The patient’s name or other i…

10417 ANNUAL REPORTS 10417.1 You must submit to the Department an annual report on in writing or electronic equivalent. You must submit an annual report by January 1 of each year. You must clearly identify your annual report as such. Your annual report must include: (a) Your Cent…

10418 INDIVIDUAL ADVERSE EVENT REPORTING REQUIREMENTS FOR IMPORTERS 10418.1 When reporting deaths or serious injuries, an importer shall submit a report to the Department, and a copy of this report to the manufacturer, as soon as practicable but no later than thirty (30) calendar…

10419 INDIVIDUAL ADVERSE EVENT REPORT DATA ELEMENTS FOR IMPORTERS 10419.1 You must include the following information in your report, if the information is known or should be known to you: (a) For patient information, you must submit the following: The patient’s name or other iden…

10420 INDIVIDUAL ADVERSE EVENT REPORTS REQUIREMENTS FOR MANUFACTURERS 10420.1 A manufacturer shall report to the Department no later than thirty (30) calendar days after the day that it receives or otherwise becomes aware of information, from any source, that reasonably suggests …

10421 INDIVIDUAL ADVERSE EVENT REPORT DATA ELEMENTS FOR MANUFACTURERS 10421.1 You must include the following information in your reports, if known or reasonably known to your patient information, you must submit the following: The patient’s name or other identifier; The patient’s…

10422 FIVE (5)-DAY REPORTS FOR MANUFACTURERS 10422.1 You must submit a five (5)-day report to us no later than five (5) work days after the day that you become aware of: An MDR reportable event that necessitates remedial action to prevent an unreasonable risk of substantial harm …

10423 SUPPLEMENTAL REPORTS 10423.1 If you are a manufacturer, when you obtain information that you did not provide because it was not known or was not available when you submitted the initial report, you must submit the supplemental information to the Department within one (1) mo…

10424 FOREIGN MANUFACTURERS 10424.1 Every foreign manufacturer whose devices are distributed in the United States shall designate a U.S. agent to be responsible for reporting in accordance with § 10510 of this subtitle. The designated agent accepts responsibility for the duties t…

10499 DEFINITIONS 10499.1 As used in this chapter, the following terms and phrases shall have the meanings ascribed: Ambulatory surgical facility (ASF) –a distinct entity that operates for the primary purpose of furnishing same-day outpatient surgical services to patients. An ASF…

10500 WHO MUST REGISTER AND SUBMIT A DEVICE LIST 10500.1 An owner or operator of an establishment not exempt under Section 510(g) of the Act or § 10512 of this chapter who is engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of a device in…

10501 TIME FOR ESTABLISHMENT REGISTRATION AND DEVICE LISTING 10501.1 An owner or operator of an establishment who has not previously entered into an operation shall register within thirty (30) days after entering into such an operation and submit device listing information at tha…

10502 HOW AND WHERE TO REGISTER ESTABLISHMENTS AND LIST DEVICES 10502.1 The first registration of a device establishment shall be on Form FDA-2891 (Initial Registration of Device Establishment) or a similar form supplied by the Department. Subsequent annual registration shall be …

10503 INFORMATION REQUIRED OR REQUESTED FOR ESTABLISHMENT REGISTRATION AND DEVICE LISTING 10503.1 Form FDA-2891 and Form FDA-2891a or their Department equivalents are the approved forms for initially providing the information required by the Act and for providing annual registrat…

10504 AMENDMENTS TO ESTABLISHMENT REGISTRATION 10504.1 Changes in individual ownership, corporate or partnership structure, or location of an operation shall be submitted on Form FDA-2891a or its Department equivalent at the time of annual registration, or by letter if the change…

10505 UPDATING DEVICE LISTING INFORMATION 10505.1 Form FDA-2892 or its Department equivalent shall be used to update device listing information. The preprinted original document number of each form FDA-2892 or its Department equivalent on which the device was initially listed sha…

10506 ADDITIONAL LISTING INFORMATION 10506.1 Each owner or operator shall maintain a historical file containing the labeling and advertisements in use on the date of initial listing, and in use after October 10, 1978, but before the date of initial listing, as follows: For each d…

10507 NOTIFICATION OF REGISTRANT 10507.1 The Department will provide to the official correspondent, at the address listed on the form, a validated copy of Form FDA-2891 or Form FDA-2891a (whichever is applicable) or their Department equivalent as evidence of registration. A perma…

10508 INSPECTION OF ESTABLISHMENT REGISTRATION AND DEVICE LISTING 10508.1 A copy of the forms FDA-2891 that the registrant files shall be available for inspection at the Department. Upon request, verification of registration number or location of a registered establishment shall …