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 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....
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.2...
Those senior employees of a manufacturer who have the authority to establish or make changes to the manufacturer’s quality policy and quality system.2...
Manufacturer
Any person who designs, manufacturers, fabricates, assembles, or processes a finished device. Manufacturer includes but it not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing,...
Any person who designs, manufacturers, fabricates, assembles, or processes a finished device. Manufacturer includes but it not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing,...
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...
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...
Matrix
The type of sample, e.g. saliva, urine, spinal fluid, tears, blood, plasma, serum, hair....
The type of sample, e.g. saliva, urine, spinal fluid, tears, blood, plasma, serum, hair....
Matrix effect
The impact of changing a matrix on the perfomance of the assay compared to the matrix used when the assay was last cleared. This is evaluated by a matrix comparison...
The impact of changing a matrix on the perfomance of the assay compared to the matrix used when the assay was last cleared. This is evaluated by a matrix comparison...
Medical Device Reportable Event
An event that reasonably suggests that a device has or may have caused or contributed to a death or serious injury or an event about which manufacturers have received or...
An event that reasonably suggests that a device has or may have caused or contributed to a death or serious injury or an event about which manufacturers have received or...
Medical Device Reporting
This is a requirement stated in 21 CFR Part 803 – Medical Device Reporting. Under this part, medical device user facilities and manufacturers must report deaths and serious injuries to...
This is a requirement stated in 21 CFR Part 803 – Medical Device Reporting. Under this part, medical device user facilities and manufacturers must report deaths and serious injuries to...
Medical decision point
The value above or below shich a physician will alter their medical therapy or interpretation of the disease or condition....
The value above or below shich a physician will alter their medical therapy or interpretation of the disease or condition....
Method comparison
A comparison of results where an assay and either a predicate assay or a reference method are compared over the range of the new assay. The mathematical equation describing the...
A comparison of results where an assay and either a predicate assay or a reference method are compared over the range of the new assay. The mathematical equation describing the...
Near patient testing
Testing performed outside a central laboratory, e.g., home use, workplace, emergency room, physician office....
Testing performed outside a central laboratory, e.g., home use, workplace, emergency room, physician office....
Negative percent agreement
The proportion of non-reference standard negative subjects in whom the new test is negative....
The proportion of non-reference standard negative subjects in whom the new test is negative....
Negative predictive value
The proportion of non-reference standard negative subjects in whom the new test is negative....
The proportion of non-reference standard negative subjects in whom the new test is negative....
New Drug Application
For decades, the regulation and control of new drugs in the United States has been based on the New Drug Application (NDA). Since 1938, every new drug has been the...
For decades, the regulation and control of new drugs in the United States has been based on the New Drug Application (NDA). Since 1938, every new drug has been the...
Nonconformity
The nonfulfillment of a specified requirement...
The nonfulfillment of a specified requirement...
Objective clinical endpoint
Clinical signs, symptoms, and other indicators that are well recognized in the standard practice of medicine to indicate the disease or condition for the intended use of the assay....
Clinical signs, symptoms, and other indicators that are well recognized in the standard practice of medicine to indicate the disease or condition for the intended use of the assay....
Office of In Vitro Diagnostic Devices
The office within CDRH responsible for regulating in vitro diagnostic products....
The office within CDRH responsible for regulating in vitro diagnostic products....
Over-the-Counter
Drugs and devices that may be sold directly to consumers without the need for a prescription....
Drugs and devices that may be sold directly to consumers without the need for a prescription....
Overall agreement
The proportion of subjects in whom the new test and the non-reference standard give the same outcome....
The proportion of subjects in whom the new test and the non-reference standard give the same outcome....
PMA Ammendment
A submission that reports a change to a PMA that has been submitted but not approved....
A submission that reports a change to a PMA that has been submitted but not approved....
PMA Supplement
A submission that reports a change to a Class III device that has an approved PMA. A PMA supplement must be submitted before making a change affecting the safety or...
A submission that reports a change to a Class III device that has an approved PMA. A PMA supplement must be submitted before making a change affecting the safety or...
Package insert
Informational material that accompanies the instruments, reagents, and other laboratory products that gives the instructions for use of the device; contains precautions, warnings and limitations....
Informational material that accompanies the instruments, reagents, and other laboratory products that gives the instructions for use of the device; contains precautions, warnings and limitations....
Performance characteristic
A property of a test that is used to describe its quality e.g. accuracy, precision, analytical sensitivity, analytical specificity, reportable range, reference range....
A property of a test that is used to describe its quality e.g. accuracy, precision, analytical sensitivity, analytical specificity, reportable range, reference range....
Positive percent agreement
The proportion of non-reference standard positive subjects in whom the new test is positive....
The proportion of non-reference standard positive subjects in whom the new test is positive....
Positive predictive value
The likelihood that an individual with a positive test result has a particular disease or other condition, that the test is designed to detect....
The likelihood that an individual with a positive test result has a particular disease or other condition, that the test is designed to detect....
Postmarket surveillance
The active, systematic, scientifically valid collection, analysis, and interpretation of data or other information about a marketed device. means the active, systematic, scientifically valid collection, analysis, and interpretation of data...
The active, systematic, scientifically valid collection, analysis, and interpretation of data or other information about a marketed device. means the active, systematic, scientifically valid collection, analysis, and interpretation of data...
Precision
The closeness in agreement between independent test results obtained under stipulated conditions. It is typically reported as standard deviations or coefficient of variation which describes imprecision....
The closeness in agreement between independent test results obtained under stipulated conditions. It is typically reported as standard deviations or coefficient of variation which describes imprecision....
Predicate Device
A device that has been FDA cleared via a 510(k) that is used as an compator product....
A device that has been FDA cleared via a 510(k) that is used as an compator product....
Premarket Approval Application
A PMA is a submission that is required for Class III medical devices. The requirements for the contents of a PMA are presented in 21 CFR § 814.20....
A PMA is a submission that is required for Class III medical devices. The requirements for the contents of a PMA are presented in 21 CFR § 814.20....
Presciption home use
Prescription home use in-vitro diagnostic devices are intended to detect and/or measure analytes e.g. antigens, antibodies, hormones etc. in clinical specimens. They are essentially the same as other clinical lab...
Prescription home use in-vitro diagnostic devices are intended to detect and/or measure analytes e.g. antigens, antibodies, hormones etc. in clinical specimens. They are essentially the same as other clinical lab...
Prevalence
The frequency of a condition of interest at a given point in time expressed as a fraction of the number of individuals in a specified group with the condition of...
The frequency of a condition of interest at a given point in time expressed as a fraction of the number of individuals in a specified group with the condition of...
Principal Investigator
An individual who actually conducts the investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject, or, in the event of...
An individual who actually conducts the investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject, or, in the event of...
Process Validation
Establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications....
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....
Components, manufacturing materials, in-process devices, finished devices, and returned devices....
Prospective samples
Samples are obtained directly from patients enrolled in a study whose purpose is to investigate the performance of the device....
Samples are obtained directly from patients enrolled in a study whose purpose is to investigate the performance of the device....