For adverse event reporting, programs that include direct involvement by the sponsor (e.g., U.S. Food and Drug Administration [FDA]) in collecting information, for example, through routine or special surveys. (See also Passive surveillance.)
As defined by FDA in connection with medical devices, an individual between the ages of 12 and 20 (“up to 21” years).
An instance of harm during patient care or research that is not the result of the individual’s disease or medical condition. Adverse events are sometimes defined to include events that have the potential to cause harm, such as close calls or near misses that could have resulted in harm but did not.
Authorization to market a medical device that requires submission of a premarket approval application (PMA) and FDA review of safety and effectiveness.
A positive or valued outcome of an action or event.
As defined by FDA in connection with medical devices, an individual between the ages of 2 and 11 (“up to 12” years).
Class I medical devices.
Low-risk devices that need not be reviewed by FDA before marketing As specified in statute, these are (1) devices for which certain “general” controls, for example, standards for good manufacturing practices, are considered to provide reasonable assurance of the safety and effectiveness of the device or (2) devices that are not intended or represented (“purported”) to support or sustain life or play an important role in preventing impairment or that are not
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Safe Medical Devices for Children G Glossary Active surveillance. For adverse event reporting, programs that include direct involvement by the sponsor (e.g., U.S. Food and Drug Administration [FDA]) in collecting information, for example, through routine or special surveys. (See also Passive surveillance.) Adolescent. As defined by FDA in connection with medical devices, an individual between the ages of 12 and 20 (“up to 21” years). Adverse event. An instance of harm during patient care or research that is not the result of the individual’s disease or medical condition. Adverse events are sometimes defined to include events that have the potential to cause harm, such as close calls or near misses that could have resulted in harm but did not. Approval. Authorization to market a medical device that requires submission of a premarket approval application (PMA) and FDA review of safety and effectiveness. Benefit. A positive or valued outcome of an action or event. Child. As defined by FDA in connection with medical devices, an individual between the ages of 2 and 11 (“up to 12” years). Class I medical devices. Low-risk devices that need not be reviewed by FDA before marketing As specified in statute, these are (1) devices for which certain “general” controls, for example, standards for good manufacturing practices, are considered to provide reasonable assurance of the safety and effectiveness of the device or (2) devices that are not intended or represented (“purported”) to support or sustain life or play an important role in preventing impairment or that are not
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Safe Medical Devices for Children expected to pose an unreasonable risk of illness or injury. (21 USC 360c(a)(1)(A)) Class II medical devices. Devices that present more risk than Class I devices (see above). For these devices, general controls are not by themselves sufficient to provide reasonable assurance of safety and effectiveness, but sufficient information is available to develop “special controls” (for example, guidelines) for that purpose (21 USC 360(c)(a)(1)). For a Class II device to be legally marketed, the manufacturer must usually submit a notification of intent to market and receive FDA clearance under 510(k) provisions (referring to the applicable section of the Medical Device Amendments of 1976. (21 USC 360(k)) Class III medical devices. Devices that are intended to support or sustain life or play an important role in preventing impairment or that are considered to pose an unreasonable risk of illness or injury. For devices in this class, FDA has determined that general controls are inadequate to reasonably assure safety and effectiveness and that available information is insufficient to develop adequate special controls. (21 USC 360(c)(a)(1)) Class III devices usually require FDA approval. Clearance. A process for FDA to authorize a device for marketing based on a review of evidence of safety and equivalence to certain previously marketed devices; clinical evidence of safety and effectiveness is not usually required. Clinical trial. A prospective study involving human subjects that is designed to evaluate a health care intervention (e.g., device therapy, diagnostic test). Close call (see Near miss). Combination product. A product that (1) is comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity; (2) is comprised of two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products; or (3) is packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect and where upon approval of the proposed product the labeling of the approved product would need to be changed, e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose. (21 CFR 3.2(e)) Compassionate use. A mechanism for securing FDA permission for the use with an individual patient of a medical device that has not been approved or cleared for marketing. (See also Emergency use.)
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Safe Medical Devices for Children Condition-of-approval study. A study to be conducted after approval of a device to address issues of safety and effectiveness (e.g., long-term effects, effects in populations not yet studied) not sufficiently evaluated by studies submitted in support of a premarket approval application. The manufacturer agrees to perform these studies as a condition of approval. Confidential commercial information. Valuable data or information that is used in one’s business and is of a type customarily held in strict confidence or regarded as privileged and not disclosed to any member of the public by the person to whom it belongs. (21 CFR. 20.61) Correction. A type of recall that involves an on-site repair, adjustment, labeling change, destruction, or inspection of a product. Corrective action. Action to eliminate the cause(s) of an existing defect or similar product or quality problem in order to prevent recurrence. Design controls. Procedures to control the design of the device in order to ensure that specified design requirements are met. (21 CFR 820.30) Device failure. The failure of a device to perform or function as intended, including any deviations from the device’s performance specifications or intended use. (21 CFR 822.3(c)) Device malfunction. The failure of a device to meet its performance specifications or otherwise perform as intended. (21 CFR 803.3(n)) Device tracking. A process that allows manufacturers to provide certain critical information about the location of certain Class II or III devices so that they can promptly remove a device from the market when requried by the FDA. Direct benefit. A tangible positive outcome of an event or action. Distributor. Any person who furthers the distribution of a device from the original place of manufacture to the person who makes delivery or sale to the ultimate user. (21 CFR 821.3(h)) Effectiveness. The achievement of desired results in actual clinical practice. Efficacy. The achievement of desired results in controlled clinical studies. Explant. An implanted device that has been removed from a patient. General controls. Requirements (e.g., registering all manufacturing locations, following quality system regulations) that all classes of medical devices must meet to be lawfully marketed. Harm. A hurtful or adverse outcome of an action or event, whether temporary or permanent. Hazard. A potential source of harm. Human factors. [H]ow people use technology … the interaction of human abilities, expectations, and limitations, with work environments and system design (FDA, 2003s). Humanitarian Device Exemption (HDE) application. An application that is similar to a premarket approval (PMA) application but exempt from
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Safe Medical Devices for Children the effectiveness requirements of a PMA. An approved HDE authorizes marketing of a Humanitarian Use Device. Humanitarian Use Device. A device that is intended to benefit patients suffering from a disease or condition that affects fewer than 4,000 individuals in the United States per year. Implant. As defined in regulations for investigational devices: 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. To protect public health, FDA may also determine that devices placed in subjects for shorter periods are also “implants.” (21 CFR 812.3(d)) As defined in medical device tracking regulations: a device that is intended to be placed into a surgically or naturally formed cavity of the human body for more than 1 year 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. (21 CFR 821.3(f)) Importer. One who imports a device into the United States and 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 user. Does not include those who repackage or otherwise change the container, wrapper, or labeling of the device or device package. Infant. As used by FDA in relation to medical devices, individual below 2 years of age. Institutional Review Board (IRB). A group of qualified individuals charged under federal regulation with protecting the rights and welfare of people involved in research in accord with federal regulations. IRBs review and approve plans for research involving humans. Investigational device. A device that is the object of a clinical investigation or research involving one or more subjects to determine safety or effectiveness of the device. (21 CFR 812.3(g) & (h)) Label. A display of written, printed, or graphic matter upon the immediate container of a drug or other product. (FDCA 201(k)) Malfunction. The failure of a device to meet its performance specifications or to perform as intended. (21 CFR 803.3(n)) Manufacturer. Any person, including any importer (i.e., an initial distributor of an imported device), repacker, relabeler, or specifications developer who manufactures, prepares, propagates, compounds, assembles, or processes a device. (21 CFR 821.3(c)) Market withdrawal. A firm’s removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by the FDA or which involves no violation, e.g., normal stock rotation practices, routine equipment adjustments and repairs, etc. (FDA, 2002i).
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Safe Medical Devices for Children Medical device. An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component, part, or accessory, which is • recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement of them; •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 • intended to affect the structure or any function of the body of man or other animals; and • which does not achieve any of its primary intended purposes through chemical action within or on the body of man of other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. (21 USC 321(h)) Misbranded. A device is considered misbranded if it fails to meet any one of several requirements, for example, if its labeling is false or misleading or if it was made in an establishment that was not registered in accord with regulations. (21 USC 352) Near miss. An event that could have resulted in harm but did not. Sometimes described as a “close call.” Nonsignificant risk device. A device that does not pose a significant risk to the human research subjects. Studies involving such devices require IRB approval and informed consent but do not require an Investigational Device Exemption (IDE) from FDA. (See also Significant risk device.) Off-label use. (See Unlabeled use.) Passive surveillance. For adverse event reporting, a program that waits for reports from individuals or organizations without active efforts to collect information. (See Active surveillance.) Pediatric population. May refer to all children or a subgroup of children who share the same characteristics. Permanently implantable device. An implantable device is a device that is intended to be placed into a surgically or naturally formed cavity of the human body for more than 1 year 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. Postamendment device. A medical device available to consumers after the enactment of the Medical Device Amendments of 1976. Postmarket. Processes including evaluations, activities, and decisions that occur after regulatory approval, clearance, or registration of a medical product for marketing. Postmarket study commitments. Refers collectively to condition-of-approval studies and Section 522 Postmarket Surveillance studies. Postmarket surveillance of medical devices. Programs that seek to protect
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Safe Medical Devices for Children public health by systematically collecting, analyzing, and communicating information about events involving or potentially involving legally marketed medical devices. Postmarket Surveillance (Section 522) study. Required postmarket activity that may be ordered after the approval or clearance of certain Class II or Class III devices. Preamendment device. A medical device available to consumers before enactment of the Medical Device Amendments of 1976. (See Predicate device.) Predicate device. A device that a) was legally marketed in the U.S. prior to May 28, 1976, or b) has been reclassified from Class III to Class II or I, OR c) was found to be substantially equivalent through the premarket notification (510(k)) process. Premarket. Processes including evaluations, decisions, and other activities that occur prior to the marketing of a medical product. Premarket notification (510(k) process). Process for securing FDA clearance to market devices that are substantially equivalent to devices marketed prior to May 28, 1976. 510(k) refers to the relevant section of the Federal Food, Drug, and Cosmetic Act. Public health notification. An FDA announcement used to quickly disseminate device-related safety information beneficial to healthcare providers. Recently the FDA decided to comprehensively apply the term to what had been distinguished as Safety Alerts, Public Health Notifications, and Public Health Advisories. Quality systems regulation. General control requirements that cover methods, facilities and controls related to medical device design (prior to actual production), manufacture, packing, storage, and installation. These regulations include Good Manufacturing Practices and seek to prevent safety problems related to design deficiencies. Rare condition. A condition that affects or is manifested in (causes symptoms in) fewer than 4,000 individuals in the United States per year. Recall. A firm’s voluntary or directed removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. Recall does not include a market withdrawal or a stock recovery. (21 CFR 7) Class I recalls involve dangerous or defective products that have a reasonable probability of causing serious health problems or death. Class II recalls involve products that might be expected to cause a temporary health problem or that pose only a slight threat of a serious nature. Class III recalls involve products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing regulations. Registry. A system for collecting information about a class of individuals or patients who have in common a disease, injury, condition, medical pro-
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Safe Medical Devices for Children cedure or product, or similar characteristic. The term registry is sometimes used narrowly to refer to the database itself and sometimes more broadly to refer to analyses and studies based on registry information. Risk. A potential harm or the potential of an action or event to cause harm. Risk management. A systematic application of policies, procedures, and practices to the analysis, evaluation, and control of risks. It is a key component of quality management systems, and a central requirement of the implementation of Design Controls in the Quality Systems Regulation (FDA, 2000b). Safe. A relative term, defined as: “there is reasonable assurance that a device is 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.” (21 CFR 860.7(d)(1)) Safety alert (see Public health notification). Safety signal. An apparent excess of reported adverse events associated with a product. Sometimes a single, well-documented report may be sufficient to signal a safety problem. Serious adverse health consequence. Any significant adverse experience related to a device, including events which are life threatening or which involve permanent or long-term injury or illness. (21 CFR 821.3(e)) Serious injury. An injury or illness that (1) is life threatening; (2) results in permanent impairment of a body function or permanent damage to body structure; or (3) requires medical or surgical intervention to preclude permanent impairment or damage. Significant risk device. A device that cannot undergo tests in humans without IRB approval and FDA approval of an application for an Investigational Device Exemption. Such a device is one that: (1) is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject; (2) is purported or represented to be for a use in supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject; (3) is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; or (4) otherwise presents a potential for serious risk to the health, safety, or welfare of a subject. (21 CFR 812.3(m)) Special controls. Requirements for Class II medical devices that are intended to ensure safety and effectiveness. Unlike general controls, special controls may vary for different types of devices. Special controls
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Safe Medical Devices for Children include performance standards, guidelines, patient registries, and postmarket surveillance. (FDCA section 513(a)(1)(B)) Substantially equivalent. When a device (a) has same intended use and has same technological characteristics as a predicate device, OR (b) has the same intended use but different technological characteristics if these differences do not raise different questions of safety and effectiveness and if information is provided to show that the device is as safe and effective a legally marketed device. Surveillance. The ongoing, systematic collection, analysis, interpretation, and dissemination of data about a health-related event for use in public health action to reduce morbidity and mortality and to improve health (CDC, 2001). Trade Secret. Information that may consist of any commercially valuable plan, formula, process, or device that is used for the making, preparing, compounding, or processing of trade commodities and that can be said to be the end product of either innovation or substantial effort. There must be a direct relationship between the trade secret and the productive process. Unlabeled use. Use of a drug or medical device for a purpose, patient group, or other use that is not specifically approved by the FDA for use as indicated on the product’s label. Such use by physicians is considered part of the practice of medicine, which FDA—by statute—does not regulate. Sometimes described as “off-label” use. User facility. A hospital, an ambulatory surgical facility, a nursing home, an outpatient diagnostic facility, or an outpatient treatment facility that is not a physician’s office. An outpatient treatment facility includes home health care groups, ambulance providers, and rescue services. (21 CFR 803.3(f) & (v)) Withdrawal of FDA approval. An order withdrawing approval of a PMA if, from any information available to the Agency, FDA determines that certain requirements were not fulfilled. (21 CFR 814.46(a)) ACRONYMS AND ABBREVIATIONS 510(k) premarket notification AAP American Academy of Pediatrics ACC American College of Cardiology ACHRE Advisory Committee on Human Radiation Experiments AHRQ Agency for Health Research and Quality AMA American Medical Association AMC academic medical center CBER Center for Biologics Evaluation and Research CDC Centers for Disease Control and Prevention
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Safe Medical Devices for Children CDER Center for Drug Evaluation and Research CDRH Center for Devices and Radiological Health CERT Centers for Education and Research on Therapeutics CHCA Child Health Corporation of America CMS Centers for Medicare and Medicaid Services CONSORT Consolidated Standard of Reporting Trials CRO contract research organization CT computer-assisted tomography DHHS U.S. Department of Health and Human Services DSaRM Drug Safety and Risk Management Advisory Committee ECLS Extracorporeal Life Support ECMO Extracorporeal Membrane Oxygenation ECRI formerly, the Emergency Care Research Institute EU European Union FDA U.S. Food and Drug Administration GAO Government Accountability Office (formerly General Accounting Office) GHTF Global Harmonization Task Force GMDN Global Medical Device Nomenclature GMP Good Manufacturing Practices HDE Humanitarian Device Exemption HIPAA Health Insurance Portability and Accountability Act of 1996 HUD Humanitarian Use Device ICD International Classification of Diseases ICH International Conference on Harmonisation IDE Investigational Device Exemption IOM Institute of Medicine IRB Institutional Review Board ISO International Organization for Standardization ISPE International Society for Pharmacoepidemiology JCAHO Joint Commission on the Accreditation of Healthcare Organizations LVAD left ventricular assist device
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Safe Medical Devices for Children M-DEN Medical Device Engineering Network MDR Medical Device Reporting MedSun Medical Product Surveillance Network MRI magnetic resonance imaging NACHRI National Association of Children’s Hospitals and Related Institutions NAS National Academy of Sciences NEISS National Electronic Injury Surveillance System NHLBI National Heart Lung and Blood Institute NICHD National Institute for Child Health and Human Development NIH National Institutes of Health NRC National Research Council NYPORTS New York Patients Occurrence and Tracking System OIG Office of Inspector General PDP product development protocol PHTS Pediatric Heart Transplant Study PMA premarket approval application QuIC Quality Interagency Coordination Task Force SEC Securities and Exchange Commission STAMP Systematic Technical Assessment of Medical Products STROBE Strengthening the Reporting of Observational studies in Epidemiology UMDNS Universal Medical Device Nomenclature System VAERS Vaccine Adverse Event Reporting System PUBLIC LAWS P.L. 59–384 Pure Food and Drugs Act of 1906 P.L. 75–717 Federal Food, Drug, and Cosmetic Act of 1938 P.L. 87–78 Drug Amendments of 1962 P.L. 94–295 Medical Device Amendments of 1976 P.L. 99–660 National Childhood Vaccine Injury Act of 1986 P.L. 101–629 Safe Medical Devices Act of 1990
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Safe Medical Devices for Children P.L. 102–300 Medical Device Amendments of 1992 P.L. 104–191 Health Insurance Portability and Accountability Act of 1996 P.L. 105–115 Food and Drug Administration Modernization P.L. 106–310 Children’s Health Act of 2000 P.L. 107–109 Best Pharmaceuticals for Children Act of 2002 P.L. 107–188 Public Health Security and Bioterrorism Preparedness and Response Act of 2002 P.L. 107–250 Medical Device User Fee and Modernization Act of 2002 P.L. 108–155 Pediatric Research Equity Act of 2003 P.L. 108–214 Medical Devices Technical Corrections Act of 2004