D.C. Mun. Regs. tit. 22, r. 22-B10899
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 radiation as a result of the manufacturing, testing, or use of an electronic product.
Act - the Federal Food, Drug, and Cosmetic Act, approved June 25, 1938, 21 U.S.C. § 301, et seq.
Ambulatory surgical facility (ASF) - a distinct entity that operates for the primary purpose of furnishing same day outpatient surgical services to patients. An ASF may be either an independent entity (for example, not a part of a provider of services or any other facility) or operated by another medical entity (such as, under the common ownership, licensure, or control of an entity). An ASF is subject to this regulation regardless of whether it is licensed by a federal, state, municipal, or local government or regardless of whether it is accredited by a recognized accreditation organization. If an adverse event meets the criteria for reporting, the ASF must report that event regardless of the nature or location of the medical service provided by the ASF.
Audiologist - any person qualified by training and experience to specialize in the evaluation and rehabilitation of individuals whose communication disorders center in whole or in part in the hearing function. In some states audiologists must satisfy specific requirements for licensure.
Beam blocking device - a movable or removable portion of any enclosure around a cold-cathode gas discharge tube, which may be opened or closed to permit or prevent the emergence of an exit beam.
Become aware - when an employee of the entity required to report has acquired information that reasonably suggests a reportable adverse event has occurred.
Business day - Monday through Friday, except federal holidays.
Caused or contributed - when a death or serious injury was or may have been attributed to a medical device, or that a medical device was or may have been a factor in a death or serious injury, including events occurring as a result of:
Chassis family - a group of one (1) or more models with all of the following common characteristics:
Classification name - the term used by the Department and its classification panels to describe a device or class of devices for purposes of classifying devices under Section 513 of the Federal Food, Drug, and Cosmetic Act.
Class III certification - a certification that the submitter pursuant to 21 U.S.C. § 360(k) has conducted a reasonable search of all known information about the class III device and other similar, legally marketed devices.
Class III summary - a summary of the types of safety and effectiveness problems associated with the type of device being compared and a citation to the information upon which the summary is based. The summary must be comprehensive and describe the problems to which the type of device is susceptible and the causes of such problems.
Cold-cathode gas discharge tube - an electronic device in which electron flow is produced and sustained by ionization of contained gas atoms and ion bombardment of the cathode.
Commerce -
Commercial distribution - any distribution of a device intended for human use which is held or offered for sale but does not include the following:
Design input - the physical and performance requirements of a device that are used as a basis for device design.
Design output - the results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the device master record. The total finished design output consists of the device, its packaging and labeling, and the device master record.
Design review - a documented, comprehensive, systematic examination of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.
Design validation - establishing by objective evidence that device specifications conform to user needs and intended use(s).
Device history record (DHR) - a compilation of records containing the production history of a finished device.
Device master record (DMR) - a compilation of records containing the procedures and specifications for a finished device.
Device user facility - a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility as defined in this subsection, which is not a physician's office as defined in this subsection. School nurse offices and employee health units are not device user facilities.
Diagnostic radiology facility - any facility in which an x-ray system(s) is used in any procedure that involves irradiation of any part of the human body for the purpose of diagnosis or visualization. Offices of individual physicians, dentists, podiatrists, and chiropractors, as well as mobile laboratories, clinics, and hospitals are all examples of diagnostic radiology facilities.
Director -the Director of the Department of Health or his or her designee.
Dispenser - any person, partnership, corporation, or association engaged in the sale, lease, or rental of hearing aids to any member of the consuming public or any employee, agent, sales person, or representative of such a person, partnership, corporation, or association.
Department -the District of Columbia Department of Health.
Distributor - a person engaged in the business of offering electronic products for sale to dealers, without regard to whether such person is or has been primarily or customarily engaged in such business.
District standard - a performance standard.
Ear specialist - any licensed physician who specializes in diseases of the ear and is medically trained to identify the symptoms of deafness in the context of the total health of the patient, and is qualified by special training to diagnose and treat hearing loss. Such physicians are also known as otolaryngologists, otologists, and otorhinolaryngologists.
Electromagnetic radiation - includes the entire electromagnetic spectrum of radiation of any wavelength. The electromagnetic spectrum illustrated in Figure 1 includes, but is not limited to, gamma rays, x-rays, ultra-violet, visible, infrared, microwave, radiowave, and low frequency radiation.
Electronic product -
Establish - define, document (in writing or electronically), and implement.
Establishment - a place of business under one (1) management at one (1) general physical location at which a device is manufactured, assembled, or otherwise processed.
Exit beam - that portion of the radiation which passes through the aperture resulting from the opening of the beam blocking device.
Expected life of a device - the time that a device is expected to remain functional after it is placed into use. Certain implanted devices have specified "end of life" (EOL) dates. Other devices are not labeled as to their respective EOL, but are expected to remain operational through activities such as maintenance, repairs, or upgrades, for an estimated period of time.
Exposure -the sum of the electrical charges on all of the ions of one (1) sign produced in air when all electrons liberated by photons in a volume element of air are completely stopped in air divided by the mass of the air in the volume element. The special unit of exposure is the roentgen. One (1) roentgen equals 2.5810 - n4 coulombs/kilogram.
External surface - the cabinet or enclosure provided by the manufacturer as part of the receiver. If a cabinet or enclosure is not provided as part of the receiver, the external surface shall be considered to be a hypothetical cabinet, the plane surfaces of which are located at those minimum distances from the chassis sufficient to enclose all components of the receiver except that portion of the neck and socket of the cathode-ray tube which normally extends beyond the plane surfaces of the enclosure.
Five (5)-day report - a medical device report that must be submitted by a manufacturer to us under § 10422 on a form or an electronic equivalent approved under § 10406, within five (5) work days.
21 U.S.C. § 360(k) statement - a statement under 21 U.S.C. § 360c(i), asserting that all information in a premarket notification submission regarding safety and effectiveness will be made available within thirty (30) days of request by any person if the device described in the premarket notification submission is determined to be substantially equivalent. The information to be made available will be a duplicate of the premarket notification submission, including any adverse safety and effectiveness information, but excluding all patient identifiers, and trade secret or confidential commercial information, as defined in § 10602.11.
21 U.S.C. § 360(k) summary (summary of any information respecting safety and effectiveness) - a summary, submitted under 21 U.S.C. § 360c(i), of the safety and effectiveness information contained in a premarket notification submission upon which a determination of substantial equivalence can be based. Safety and effectiveness information refers to safety and effectiveness data and information supporting a finding of substantial equivalence, including all adverse safety and effectiveness information.
Humanitarian device exemption (HDE) - a premarket approval application submitted pursuant to this section seeking a humanitarian device exemption from the effectiveness requirements of 21 U.S.C. §§ 360d and 360e.
Health authority -a physician designated to administer state and local laws relating to public health.
Hearing aid - any wearable instrument or device designed for, offered for the purpose of, or represented as aiding persons with or compensating for, impaired hearing.
Hospital - a distinct entity that operates for the primary purpose of providing diagnostic, therapeutic (such as medical, occupational, speech, and physical), surgical, and other patient services for specific and general medical conditions. Hospitals include general, chronic disease, rehabilitative, psychiatric, and other special-purpose facilities. A hospital may be either independent (for example, not a part of a provider of services or any other facility) or may be operated by another medical entity (such as, under the common ownership, licensure, or control of another entity). A hospital is covered by this regulation regardless of whether it is licensed by a federal, state, municipal, or local government or whether it is accredited by a recognized accreditation organization. If an adverse event meets the criteria for reporting, the hospital must report that event regardless of the nature or location of the medical service provided by the hospital.
Humanitarian use device (HUD) - a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than four thousand (4,000) individuals in the United States per year.
Investigational device exemption (IDE) - an agreement through which the federal government permits the testing of a new medical device in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval or Premarket Notification (510(k) submission to the Food and Drug Administration.
Infrasonic, sonic (or audible) and ultrasonic waves - refers to energy transmitted as an alteration (pressure, particle displacement or density) in a property of an elastic medium (gas, liquid, or solid) that can be detected by an instrument or listener.
Initial importer - any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes the final delivery or sale of the device to the ultimate consumer or user, but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package. Any term defined in Section 201 of the Act shall have that meaning.
Lot or batch - one (1) or more components or finished devices that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits.
Malfunction - the failure of a device to meet its performance specifications or otherwise perform as intended. Performance specifications include all claims made in the labeling for the device. The intended performance of a device refers to the intended use for which the device is labeled or marketed, as defined in § 9301.
Management with executive responsibility - those senior employees of a manufacturer who have the authority to establish or make changes to the manufacturer's quality policy and quality system.
Master file - a reference source that a person submits to the Department of Health A master file may contain detailed information on a specific manufacturing facility, process, methodology, or component used in the manufacture, processing, or packaging of a medical device.
Manufacturer - any person who manufactures, prepares, propagates, compounds, assembles, or processes a device by chemical, physical, biological, or other procedure. The term includes any person who either:
Manufacturer - any person engaged in the business of manufacturing, assembling, or importing electronic products. (21 C.F.R., Subchapter J, Radiological Health).
Manufacturer or importer report number - the number that uniquely identifies each individual adverse event report submitted by a manufacturer or importer. This number consists of the following three parts:
Manufacturing material - any material or substance used in or used to facilitate the manufacturing process, a concomitant constituent, or a byproduct constituent produced during the manufacturing process, which is present in or on the finished device as a residue or impurity not by design or intent of the manufacturer.
Material change - includes any change or modification in the labeling or advertisements that affects the identity or safety and effectiveness of the device. These changes may include, but are not limited to, changes in the common or usual or proprietary name, declared ingredients or components, intended use, contraindications, warnings, or instructions for use. Changes that are not material may include graphic layouts, grammar, or correction of typographical errors which do not change the content of the labeling, changes in lot number, and, for devices where the biological activity or known composition differs with each lot produced, the labeling containing the actual values for each lot.
Maximum test voltage - one hundred thirty root mean squared volts (130 VRMS) if the receiver is designed to operate from nominal one hundred ten to one hundred twenty root mean squared volt (120-130 VRMS)power sources. If the receiver is designed to operate from a power source having some voltage other than from nominal one hundred ten to one hundred twenty root mean squared volts (110-120 VRMS) maximum test voltage means one hundred ten percent (110%) of the nominal root mean squared voltage specified by the manufacturer for the power source.
MDR - means medical device report.
MDR reportable event (or reportable event) -
Medical device -an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is:
Medical personnel - an individual who:
Model - any identifiable, unique electronic product design, and refers to products having the same structural and electrical design characteristics and to which the manufacturer has assigned a specific designation to differentiate between it and other products produced by that manufacturer.
Model family - products having similar design and radiation characteristics but different manufacturer model numbers.
Modified model - a product that is redesigned so that actual or potential radiation emission, the manner of compliance with a standard, or the manner of radiation safety testing is affected.
Newly acquired information - data, analyses, or other information not previously submitted to the agency, which may include (but are not limited to) data derived from new clinical studies, reports of adverse events, or new analyses of previously submitted data (for example, meta-analyses) if the studies, events or analyses reveal risks of a different type or greater severity or frequency than previously included in submissions to the Department of Health.
Nonconformity - the non-fulfillment of a specified requirement.
Nursing home - means:
Official correspondent - the person designated by the owner or operator of an establishment as responsible for the following:
Outpatient diagnostic facility - a distinct entity that:
Outpatient diagnostic facilities include outpatient facilities providing radiography, mammography, ultrasonography, electrocardiography, magnetic resonance imaging, computerized axial tomography, and in vitro testing. An outpatient diagnostic facility may be either independent (for example, not a part of a provider of services or any other facility) or operated by another medical entity (such as, under the common ownership, licensure, or control of an entity). An outpatient diagnostic facility is covered by this regulation regardless of whether it is licensed by a federal, state, municipal, or local government or whether it is accredited by a recognized accreditation organization. If an adverse event meets the criteria for reporting, the outpatient diagnostic facility must report that event regardless of the nature or location of the medical service provided by the outpatient diagnostic facility.
Outpatient treatment facility - a distinct entity that operates for the primary purpose of providing nonsurgical therapeutic (medical, occupational, or physical) care on an outpatient basis or in a home health care setting. Outpatient treatment facilities include ambulance providers, rescue services, and home health care groups. Examples of services provided by outpatient treatment facilities include the following: Cardiac defibrillation, chemotherapy, radiotherapy, pain control, dialysis, speech or physical therapy, and treatment for substance abuse. An outpatient treatment facility may be either independent (for example, not a part of a provider of services or any other facility) or operated by another medical entity (such as, under the common ownership, licensure, or control of an entity). An outpatient treatment facility is covered by this regulation regardless of whether it is licensed by a federal, state, municipal, or local government or whether it is accredited by a recognized accreditation organization. If an adverse event meets the criteria for reporting, the outpatient treatment facility must report that event regardless of the nature or location of the medical service provided by the outpatient treatment facility.
Owner or operator - the corporation, subsidiary, affiliated company, partnership, or proprietor directly responsible for the activities of the registering establishment.
Owner or consignee - the person who has the rights of a consignee under the provisions of Sections 483, 484, and 485 of the Tariff Act of 1930, as amended ( 19 U.S.C. §§ 1483, 1484, 1485) .
Particulate radiation -
Patient of the facility - any individual who is being diagnosed or treated or receiving medical care at or under the control or authority of the facility. This includes employees of the facility or individuals affiliated with the facility who, in the course of their duties, suffer a device-related death or serious injury that has or may have been caused or contributed to by a device used at the facility.
Permanent - irreversible impairment or damage to a body structure or function, excluding trivial impairment or damage.
Phototherapy product - means any ultraviolet lamp, or product containing such lamp, that is intended for irradiation of any part of the living human body by light in the wavelength range of two hundred to four hundred nanometers (200-400 nm.), in order to perform a therapeutic function.
Physician's office - a facility that operates as the office of a physician or other health care professional for the primary purpose of examination, evaluation, and treatment or referral of patients. Examples of physician offices include dentist offices, chiropractor offices, optometrist offices, nurse practitioner offices, school nurse offices, school clinics, employee health clinics, or freestanding care units. A physician's office may be independent, a group practice, or part of a Health Maintenance Organization.
Premarket Approval Application (PMA) - any premarket approval application for a class III medical device, including all information submitted with or incorporated by reference therein. "PMA" includes a new drug application for a device under 21 U.S.C. § 360j(1).
PMA amendment - information an applicant submits to the Department of Health to modify a pending PMA or a pending PMA supplement.
PMA supplement - a supplemental application to an approved PMA for approval of a change or modification in a class III medical device, including all information submitted with or incorporated by reference therein.
Process validation - establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.
Product - components, manufacturing materials, in- process devices, finished devices, and returned devices.
Purchaser - the first person who, for value, or as an award or prize, acquires an electronic product for purposes other than resale, and includes a person who leases an electronic product for purposes other than subleasing.
Quality - the totality of features and characteristics that bear on the ability of a device to satisfy fitness-for-use, including safety and performance.
Quality administration procedures - are those management actions intended to guarantee that monitoring techniques are properly performed and evaluated and that necessary corrective measures are taken in response to monitoring results. These procedures provide the organizational framework for the quality assurance program.
Quality assurance - the planned and systematic actions that provide adequate confidence that a diagnostic x-ray facility will produce consistently high quality images with minimum exposure of the patients and healing arts personnel. The determination of what constitutes high quality will be made by the facility producing the images. Quality assurance actions include both "quality control" techniques and "quality administration" procedures.
Quality assurance program - an organized entity designed to provide "quality assurance" for a diagnostic radiology facility. The nature and extent of this program will vary with the size and type of the facility, the type of examinations conducted, and other factors.
Quality audit - a systematic, independent examination of a manufacturer's quality system that is performed at defined intervals and at sufficient frequency to determine whether both quality system activities and the results of such activities comply with quality system procedures, that these procedures are implemented effectively, and that these procedures are suitable to achieve quality system objectives.
Quality control techniques - are those techniques used in the monitoring (or testing) and maintenance of the components of an x-ray system. The quality control techniques thus are concerned directly with the equipment.
Rework - action taken on a nonconforming product so that it will fulfill the specified DMR requirements before it is released for distribution.
Sale or purchase - includes any lease or rental of a hearing aid to a member of the consuming public who is a user or prospective user of a hearing aid.
Serious, adverse health consequences - any significant adverse experience, including those which may be either life-threatening or involve permanent or long term injuries, but excluding injuries that are nonlife-threatening and that are temporary and reasonably reversible.
Serious injury - an injury or illness that:
Service controls - all of those controls on a television receiver provided by the manufacturer for purposes of adjustment which, under normal usage, are not accessible to the user.
Specification - any requirement with which a product, process, service, or other activity must conform.
State - a state, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, and American Samoa.
Statement of material fact - a representation that tends to show that the safety or effectiveness of a device is more probable than it would be in the absence of such a representation. A false affirmation or silence or an omission that would lead a reasonable person to draw a particular conclusion as to the safety or effectiveness of a device also may be a false statement of material fact, even if the statement was not intended by the person making it to be misleading or to have any probative effect.
Television receiver - an electronic product designed to receive and display a television picture through broadcast, cable, or closed circuit television.
Thirty (30)-day PMA supplement - a supplemental application to an approved PMA in accordance with § 10608.6.
United States(designated) agent - a person residing or maintaining a place of business in the United States whom a foreign establishment designates as its agent. This definition excludes mailboxes, answering machines or services, or other places where an individual acting as the foreign establishment's agent is not physically present.
Usable picture - a picture in synchronization and transmitting viewable intelligence.
Used hearing aid - any hearing aid that has been worn for any period of time by a user. However, a hearing aid shall not be considered "used" merely because it has been worn by a prospective user as a part of a bona fide hearing aid evaluation conducted to determine whether to select that particular hearing aid for that prospective user, if such evaluation has been conducted in the presence of the dispenser or a hearing aid health professional selected by the dispenser to assist the buyer in making such a determination.
User controls - all of those controls on a television receiver, provided by the manufacturer for purposes of adjustment, which on a fully assembled receiver under normal usage, are accessible to the user.
User facility report number - the number that uniquely identifies each report submitted by a user facility to manufacturers and to us. This number consists of the following three parts:
Validation - confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.
Verification - confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.
Wholesale distributor - any person (other than the manufacturer or the initial importer) who distributes a device from the original place of manufacture to the person who makes the final delivery or sale of the device to the ultimate consumer or user.
X-ray system - an assemblage of components for the controlled production of diagnostic images with x-rays. It includes minimally an x-ray high voltage generator, an x-ray control, a tube-housing assembly, a beam-limiting device, and the necessary supporting structures. Other components that function with the system, such as image receptors, image processors, view boxes, and darkrooms, are also parts of the system.
D.C. Mun. Regs. tit. 22, r. 22-B10899