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Accidental radiation occurrence
A single event or series of events occurring in the course of the manufacturing, testing or use of any electronic product, which has resulted in injurious or potentially injurious exposure of any person to electronic product radiation as a direct result of the manufacturing, testing, or use of that product.
Adequate directions for use
Directions under which lay people can use a device safely and for the purposes for which it is intended. These must include all conditions, purposes, or uses for which a device is intended, including those for which it is prescribed, recommended or suggested in its oral, written, printed, or graphic advertising, and those for which the device is commonly used. Other elements to be included are: quantity of dose, frequency, duration, time and method of administration or application, and preparation for use.
This term refers to the Food and Drug Administration (FDA).
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. This term does not cover surveillance or inspection activities performed for the purpose of conducting a quality assurance program or undertaking complaint investigations or failure analyses of a device.
The process of testing and adjusting an in vitro diagnostic instrument, kit or test system to provide a known relationship between the measurement response and the value of the substance that is measured by the test procedure.
Center for Devices and Radiological Health (CDRH)
The Center within the Food and Drug Administration that oversees all aspects of medical device regulation for the agency.
Centers for Medicare & Medicaid Services (CMS)
The federal agency (formerly the Health Care Financing Administration (HCFA)) within the Department of Health and Human Services charged with implementing the Medicare program in the United States by administering limits on the scope of Medicare coverage with respect to all medical and health care services. CMS denies coverage for any health or medical service that has not been demonstrated to be safe and effective according to acceptable clinical evidence.
The class of devices that are subject to only general controls because they are the least risky and least complicated devices. A device usually is in Class I if general controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device. A Class I device is not life-supporting or sustaining, nor is it for a use of substantial importance in preventing impairment of human health. Such a device does not present a potential unreasonable risk of illness or injury.
The class of devices that are or eventually will be subject to the requirements of a performance standard promulgated by the Food and Drug Administration. A device is in Class II if general controls alone are insufficient to provide reasonable assurance of its safety and effectiveness and there is sufficient information to establish a performance standard to provide such assurance.
The class of devices for which premarket approval is or will be required. A device is in Class III if insufficient information exists either to determine that general controls are sufficient to determine that general controls would provide reasonable assurance of its safety and effectiveness, or to establish a performance standard to provide such assurance. In addition, the device is Class III if it is life-supporting or life-sustaining or for a use which is of substantial importance in preventing the impairment of human health, or if the device presents a potential unreasonable risk of illness or injury.
Class I recall
This type of recall is used when there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Class II recall
This type of recall is used when use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or when the probability of serious adverse health consequences is remote.
Class III recall
This type of recall is used when the use of, or exposure to, a violative product is not likely to cause adverse health consequences.
One of several advisory committees established by the Commissioner of Food and Drugs for the purpose of making recommendations to the Commissioner on the classification and reclassification of devices, and for other purposes.
A specific series of questions prepared by the Commissioner of Food and Drugs for use as guidelines by classification panels preparing recommendations to the Commissioner regarding classification, and by petitioners submitting petitions for reclassification. The questions relate to the safety and effectiveness characteristics of a device and the answers are designed to help the Commissioner determine the proper classification of a device.
Any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug Administration (FDA) or the results of which are intended to be submitted to, or held for inspection by, the FDA.
Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88)
A law that was enacted to protect the public from inaccurate laboratory test results which swept thousands of previously unregulated laboratories (including physician office laboratories) into the federal regulatory system. Provisions in CLIA ’88 mandated that manufacturers’ quality control instructions for in vitro diagnostic systems could be “cleared” through the Food and Drug Administration.
Therapeutic and diagnostic products that combine drugs, devices and/or biological products.
This term, as used in the Federal Food, Drug, and Cosmetic Act and Food and Drug Administration regulations, refers to the Commissioner of Food and Drugs.
Records that document written and oral complaints relative to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device, and which indicate whether or not an investigation was made, and what the rationale was for either decision.
Any material, substance, piece, part, or assembly used during device manufacture which is intended to be included in a finished device.
Consumer Product Safety Act (CPSA)
This Act authorizes the Consumer Product Safety Commission to regulate consumer products, the definition of which excludes drugs, devices and components.
A device intended for medical purposes for use in in vitro diagnostic test systems to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical variation.
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.
A correction is the repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a product, without its physical removal to another location.
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.
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 are identified by the Commissioner of Food and Drugs after consultation with the Device Good Manufacturing Practice Advisory Committee authorized under section 520(f) of the Federal Food, Drug and Cosmetic Act.
Any operation in the manufacture of a critical device which, if performed improperly, can be reasonably expected to cause the failure of a critical device or to affect its safety or effectiveness.
Devices intended for highly specific use and very limited distribution, which are not subject to premarket notification or premarket approval requirements.
The term “device” is defined in the Federal Food, Drug, and Cosmetic Act generally as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is (1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.”
The failure of a device to perform or function as intended, including any deviations from the device’s performance specifications or intended use.
A group of one or more devices manufactured by the same manufacturer with the same basic design and performance characteristics related to safety and effectiveness, the same intended use, and, where applicable, the same device classification.
Device history record
A compilation of records containing the complete production history of a finished device.
Device master record
A compilation of records containing the design, formulation, specifications, complete manufacturing procedures, quality assurance requirements, and labeling of a finished device.
Any person who furthers the marketing of a device from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer or user, but who does not repackage or otherwise change the container, wrapper, or labeling of the device or the device package.
The entire electromagnetic spectrum of radiation of any wavelength, including gamma rays, X-rays, ultraviolet, visible, infrared, microwave, and low-frequency radiations.
Any manufactured or assembled product which, when in operation, contains or acts as part of an electronic circuit and emits (or in the absence of effective shielding or other controls would emit) electronic product radiation. An electronic product also is any manufactured or assembled article which is intended for use as a component, part, or accessory to the above-named product, which when in operation emits (or in the absence of effective shielding or other controls would emit) such radiation.
Electronic product radiation
Any ionizing or non-ionizing electromagnetic or particulate radiation, or any sonic, infrasonic, or ultrasound wave, which is emitted from an electronic product as the result of the operation of an electronic circuit in such product.
Electronic Product Radiation Control (EPRC)
A set of requirements for radiation-emitting devices, including pre- and post-marketing requirements and applicable performance standards, designed to reduce the exposure of the public to all unnecessary hazardous radiation from electronic products while allowing medical benefit.
The use of a device on a human subject in a life-threatening situation in which there is not sufficient time to obtain institutional review board (IRB) approval.
Environmental Protection Agency (EPA)
The EPA is the federal agency charged with the development of radiation control policy. However, the Food and Drug Administration retains jurisdictional power over radiation-emitting medical devices. The FDA and the EPA coordinate in the regulation of germicides used for sterilization devices.
A place of business under one management or at one general physical location at which a device is manufactured, assembled, or otherwise processed.
Federal Trade Commission (FTC)
The federal agency with authority to regulate, among other things, false advertising claims, including statements in product labeling. While the FTC focuses primarily on advertising, the Food and Drug Administration primarily regulates labeling.
Any person who distributes a tracked device intended for use by a single patient over the useful life of the device to the patient, including licensed practitioners, retail pharmacies, hospitals, and other types of device user facilities.
A device, or any accessory to a device, which is suitable for use, whether or not packaged or labeled for commercial distribution.
Food and Drug Administration (FDA)
The federal agency within the Department of Health and Human Services that has jurisdiction over food, drug and device products that are intended for use in humans or animals and any cosmetic and biologic intended for human use. The FDA enforces laws enacted by Congress and regulations promulgated by the agency to protect the consumer’s health and safety.
Food and Drug Administration Amendments Act of 2007 (FDAAA)
FDAAA (Pub. L. No. 110-85) included the Medical Device User Fee Amendments of 2007 (MDUFA), which reauthorized the device user fee program first established by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). FDAAA also extended authorization for third-party review of 510(k) submissions, authorized establishment inspections conducted by accredited persons (third parties), called for establishment of a system of unique device identification, and set new requirements for reprocessed single-use devices. In addition, FDAAA included the Pediatric Medical Device Safety and Improvement Act of 2007 and the Pediatric Research Equity Act of 2007, two provisions designed to expand the development and accessibility of devices for children.
Food and Drug Administration Modernization Act of 1997 (FDAMA)
The statute (Pub. L. No. 111-353) primarily was intended to streamline the regulatory process and to reduce the regulatory burden to improve patient access to breakthrough technologies. Specifically, the statute provides that the FDA will consider the least burdensome means of demonstrating substantial equivalence and will request information “accordingly.” FDAMA also provided that the FDA will consider the least burdensome appropriate means of evaluating device effectiveness “that would have a reasonable likelihood of resulting in approval.” The statute also eased a range of other regulatory burdens, providing for expedited processing of PMA applications for certain devices intended to treat or diagnose life-threatening diseases or conditions; expanding the availability of investigational device exemptions (IDEs) and humanitarian device exemptions (HDEs); and exempting most Class I devices from the need for a 510(k) submission.
Four-of-a-kind use of PMA data
After a fourth device of the same type is approved by the Food and Drug Administration (which is determined by evaluating the technologies, principles of operation and intended uses) manufacturers may use the research data in their applications for new devices of that same type. After the fourth-of-a-kind device is approved, this safety and effectiveness research data will be made available to the public.
A grouping of devices that do not differ significantly in purpose, design, materials, energy source, function, or any other feature related to the safety and effectiveness, and for which similar regulatory controls are sufficient to provide reasonable assurance of safety and effectiveness.
Good Manufacturing Practice (GMP) Regulation
This regulation, designed to ensure consistent product quality, was established July 21, 1978. It outlines goals for manufacturing and related practices and general ways to achieve those goals (for both critical and non-critical devices) in order to prevent the production of defective products.
Devices that are intended to benefit patients in the treatment and diagnosis of diseases or conditions that affect fewer than 4,000 individuals in the United States. Such devices may be exempted from premarket approval applications.
An individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy individual or a patient.
A device that is placed into a surgically or naturally formed cavity of the human body if it is intended to remain there for a period of 30 days or more. The Food and Drug Administration may determine that devices placed in subjects for shorter periods also are implants, in order to protect public health.
A system used by the Food and Drug Administration to alert District Import Offices and U.S. Customs and Border Protection to automatically detain shipments of articles that are suspected to have problems, or that are manufactured by a foreign distributor that repeatedly has violated the Federal Food, Drug and Cosmetic Act.
The initial distributor of an imported device who is required to register with the Food and Drug Administration. Brokers, jobbers or warehousers that perform services only for a person who furthers the marketing of a device are not considered importers.
Files kept by user facilities that contain documents or other information, including medical files and patient records, that relate to adverse events that may have been device-related, regardless of whether or not the facility ultimately determines the event is reportable.
A remedy against a person, including individuals or corporations, that orders that person to do or not do something.
Establishing confidence that process equipment and ancillary systems are capable of consistently operating within established limits and tolerances.
Any public or private entity or agency, including federal, state and other agencies.
Institutional review board (IRB)
Any board, committee or other group formally designated by an institution to review biomedical research involving humans as subjects, to approve the initiation of such research and periodically review it.
The objective intent of the persons legally responsible for the labeling of devices, which include labeling claims, advertising matter, or oral or written statements by such persons or their representatives.
As defined by the Federal Food, Drug and Cosmetic Act, interstate commerce means commerce between and state or territory and any commerce within the District of Columbia or within any other territory not organized with a legislative body. Interstate commerce is presumed for medical devices.
A device, including a transitional device, that is the object of an investigation.
Investigational device exemption (IDE)
An exemption from the Federal Food, Drug and Cosmetic Act which would permit unapproved devices to be distributed in interstate commerce so that their safety and effectiveness can be ascertained when a device has no track record of safety and effectiveness.
An individual who actually conducts a clinical investigation, i.e., under whose immediate direction a test article is administered or dispensed to. In the case of a team investigation, the leader of that team is the investigator.
In vitro diagnostic products
Those reagents, instruments and systems intended for use in the diagnosis of disease or other conditions. Such products are intended for use in the collection, preparation and examination of specimens taken from the human body, and are defined as medical devices.
The term labeling means all labels and other written, printed or graphic matter upon any article or any of its containers or wrappers, or accompanying such article.
A physician, dentist or other health care practitioner licensed by the law of the state in which he or she practices.
Life-supporting or life-sustaining device
A device that is essential to, or that yields information that is essential to, the restoration or continuation of a bodily function important to the continuation of human life.
The failure of a device to meet any of its performance specifications or otherwise to perform as intended.
Any person, including any repacker and/or relabeler, who manufactures, fabricates, assembles or processes a finished device. Persons who solely distribute a finished device are distributors, not manufacturers.
Any material, such as cleaning agents, mold-release agents, lubricating oil or other substances used to facilitate a manufacturing process and not intended by the manufacturer to be included in the finished device.
This occurs when a manufacturer’s removal or correction of a distributed product involves a minor violation which would not be subject to legal action by the Food and Drug Administration, or which involves no violation, e.g. normal stock rotation practices, routine equipment adjustments and repairs, etc.
A reference source that a person submits to the Food and Drug Administration that may contain detailed information on a specific manufacturing facility, process, methodology or component used in the manufacture, processing or packaging of a medical device.
Includes any change or modification in the labeling or advertisements that affect the identity or safety and effectiveness of the device. These changes may include, but are not limited to, changes in the common or usual proprietary name, declared ingredients or components, intended use, contraindications, warnings or instructions for use. Non-material changes may include graphic layouts, grammar or correction of typographical errors that do not change the content of the labeling, and changes in lot number.
Medical Device Amendments of 1976
This law was enacted by Congress in 1976 and gave the Food and Drug Administration the authority to require premarket review for devices. A key feature of the ’76 Amendments was a classification scheme that placed all devices into one of three classes.
Medical device report (MDR)
A report that must be filed with the Food and Drug Administration when a manufacturer learns of an adverse event that reasonably suggests there is a probability that a device has caused, or contributed to, a death, serious injury or serious illness, or of a malfunction that reasonably suggests that if the malfunction were to recur, it would be likely to cause or contribute to a death, serious illness or serious injury.
Medical Device User Fee and Modernization Act of 2002 (MDUFMA)
This statute (Pub. L. No. 107-250) was designed to speed FDA approval and clearance of new devices by instituting a system of manufacturer user fees to help cover the costs of the agency’s premarket device reviews. MDUFMA also established a system of FDA performance goals for timely product reviews tied to the level of the agency’s annual funding. Small businesses were subject to reduced user fees. The statute also provided for third-party inspections of manufacturers of Class II and Class III devices and authorized the FDA to set up a program of third-party inspector accreditation; established the Office of Combination Products to promote premarket review and provide consistent postmarket regulation of combination products; authorized electronic labeling for prescription devices intended for use in health care facilities; and set new labeling requirements for reprocessed single-use devices.
The risks of harm anticipated in proposed research that are not greater (in probability and magnitude) than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Any device user facility, rental company, or any other entity that distributes a life-sustaining or life-supporting device intended for use by more than one patient over the useful life of the device.
Any finished device other than a critical device.
Owner or operator
The corporation, subsidiary, affiliated company, partnership or proprietor directly responsible for the activities of the registering establishment.
Charged particles which have a different kinetic energy to product ionization or atomic or electron excitation by collision, electrical attractions, or electrical repulsion, or, uncharged particles, which can initiate a nuclear transformation or liberate charged particles, having sufficient kinetic energy to produce ionization or atomic or electron excitation by collision.
Permanently implantable device
A device that is intended to be placed into a surgically or naturally formed cavity of the human body to continuously assist, restore or replace the function of an organ system or structure of the human body throughout the useful life of the device.
Any individual, partnership, corporation, association, scientific or academic establishment, government agency (or organizational unit of) or any other legal entity.
Information an applicant submits to the Food and Drug Administration to modify a pending premarket approval (PMA) application or a pending PMA supplement.
All data and information submitted with or incorporated by reference in the premarket approval (PMA) application, and IDE incorporated in the PMA, any PMA supplement, and reports, any master files or other related submissions.
A supplemental application to an approved premarket approval (PMA) application for approval of a change or modification in a Class III medical device, including all information submitted with or incorporated by reference therein.
Devices that entered interstate commerce after May 28, 1976.
Devices that were in commercial distribution on or before May 28, 1976.
Premarket approval (PMA) application
The process by which Class III medical devices are approved for the purpose of entering interstate commerce. A PMA must include labeling that shows the intended use of the device, clinical and non-clinical safety and effectiveness data, and a detailed summary of the data contained therein.
Premarket notification (510(k))
The process by which persons intending to market devices notify the Food and Drug Administration at least 90 days before introducing a device into interstate commerce. This notification must include a product classification based on safety and effectiveness data. The Food and Drug Administration then determines if the product is substantially equivalent to a device that already is legally marketed. If it is, the new device will be subject to the same regulatory requirements as the older device.
Pre-production design validation
A process to demonstrate that the components of a device, singly or in combination, will perform in a manner consistent with their purported purpose. Pre-production design validation requirements will require manufacturers to originate and evaluate a device’s design by appropriate laboratory and bench testing.
Process performance qualification
Establishing confidence that the manufacturing process is effective and reproducible.
Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.
Product performance qualification
Establishing confidence through appropriate testing that the finished product produced by a specified process meets all release requirements for functionality and safety.
Validation conducted prior to the distribution of either a new product, or a product made under a revised manufacturing process, where the revisions may affect the product’s characteristics.
All activities necessary to assure and verify confidence in the quality of the process used to manufacture a finished device.
A firm’s removal or correction of a marketed product that the Food and Drug Administration considers to be in violation of the Federal Food, Drug and Cosmetic Act. Recalls do not include market withdrawals or stock recoveries.
A planned specific course of action to be taken in conducting a specific recall. Any recall strategy should address the depth of recall, the need for public warnings, and the extent of the effectiveness checks for the recall.
A recalling firm is a manufacturer that initiates a recall, or, in the case of a Food and Drug Administration-requested recall, the manufacturer that has the primary responsibility for the manufacture and marketing of the product to be recalled.
A submission seeking reclassification of a device.
Any recall, repair, modification, adjustment, relabeling, destruction, inspection (including patient monitoring), notification or any other action that is initiated by a manufacturer or importer in response to adverse event information it receives.
A device that has had its sale, distribution or use restricted by the Commissioner of Food and Drugs to be sold distributed, or used only upon the written or oral authorization of a licensed practitioner or upon such other conditions as the Commissioner may prescribe.
Validation of a process for a product already in distribution based on accumulated production, testing and control data.
Safe Medical Devices Act of 1990 (SMDA)
This Act was passed by Congress to protect consumers by providing for an enhanced postmarket device information system, including a requirement for user reporting, manufacturer reporting, distributor reporting and device tracking. The law also augmented the Food and Drug Administration’s enforcement authority by granting the agency subpoena power and the power to order mandatory recalls and levy administrative civil penalties for violations of the Federal Food, Drug and Cosmetic Act.
A device is considered to be safe when it can be determined, based upon valid scientific evidence, that the probable benefits to health from use of the device for its intended uses and conditions of use, when accompanied by adequate directions and warnings against unsafe use, outweigh any probable risks.
A voluntary communication issued by device manufacturers or the Food and Drug Administration to reduce or eliminate risk by informing health professionals (and other appropriate persons) of a situation that may present an unreasonable risk of substantial harm to the public health presented by a device in commercial distribution and intended for human use.
The collection of physical samples of imported products from device shipments by the Food and Drug Administration.
A remedy sought by the Food and Drug Administration wherein the agency gains control of an allegedly violative product without any showing, except the allegations of a complaint.
An injury that is life-threatening, that results in permanent impairment of a body function or permanent damage to a body structure, or that necessitates medical or surgical intervention by a health care professional to either preclude such permanent damage or to relieve unanticipated temporary impairment or damage.
A person who initiates a clinical investigation, but who does not actually conduct the investigation.
An individual who both initiates and actually conducts, alone or with others, a clinical investigation. This term applies only to individuals, and not corporations or agencies.
A firm’s removal or correction of a product that has not been marketed or that has not left the direct control of the firm, i.e., the product is located on the premises owned by, or under the control of the firm, and no portion of the lot has been released for sale or use.
Substantial equivalence (SE)
A device that the Food and Drug Administration has found to have the same intended use as another device and to have either (1) the same technological characteristics as the other device, or (2) different technological characteristics but that is as safe and effective as the other device and does not raise different questions of safety and effectiveness, is substantially equivalent to the other device.
Supplemental data sheet
Information compiled by a classification panel or submitted in a petition for device reclassification.
A device that the Food and Drug Administration considered to be a new drug or an antibiotic drug before May 28, 1976.
Unanticipated adverse device effect
Any serious adverse effect on health or safety, or any life-threatening problem or death caused by, or associated with, a device, if that adverse event was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including supplements), or any other unanticipated serious problem associated with a device that relates to the rights, safety or welfare of subjects.
A hospital, ambulatory surgical facility, nursing home, or outpatient diagnostic or treatment facility that is not a physician’s office.
Valid scientific evidence
Evidence from well-controlled investigations, partially controlled studies, studies and objective trials without matched controls, well-documented case histories conducted by qualified experts, and reports of significant human experience with a marketed device, from which it can fairly and responsibly be concluded by qualified experts that there is a reasonable assurance of the safety and effectiveness of a device under its conditions of use.
A written plan stating how validation will be conducted, including test parameters, product characteristics, production equipment and decision points on what constitutes acceptable test results.
A rapid visual examination of imported merchandise for physical damage, including storage or in-transit water damage, damage due to spills of other cargo, adverse environmental contamination, rodent or insect activity, physical color or odor problems, and labeling compliance.
A detailed examination of imported merchandise to determine if products appear to be in compliance with Food and Drug Administration requirements. This method generally is not used for medical devices.