Glossary of Related Terms
What is an Adulterated Device?
A medical device is considered “adulterated” if any of its manufacturing or quality processes do not comply with Good Manufacturing Practices.
What are Good Manufacturing Practices?
Good Manufacturing Practices (also known as GMPs) require that manufacturers create and use a quality control system for the design and production of medical devices sold in the United States. For FDA-regulated medical devices, GMP requirements are codified in the Quality System Regulation (QSR). The QSR requires that various specifications and controls be established and used consistently for design, manufacturing, installation and service of medical devices. In addition, quality data and complaints must be captured, documented and analyzed to identify, assess severity and correct quality problems. All of these steps help assure that medical devices are safe and effective for their intended use. If any of these steps are not followed, the device may be deemed to be adulterated.
What does Misbranded mean?
A device is considered to be “misbranded” if its labeling is deemed false or misleading, or if the directions for use or warnings on the label are determined to be inadequate. It could also mean that the appropriate reports, such as Medical Device Reports (MDRs) were not timely filed with the FDA, including reports of certain adverse events.
What is the difference between Adulterated and Misbranded?
Adulterated relates to the way the device was manufactured and documented. Misbranded relates to the way the device was labeled and marketed.
What are FDA Observations?
Audit Report Observations stem from an FDA inspection of an FDA registered facility. The FDA routinely inspects device manufacturing plants to determine whether they are complying with Good Manufacturing Practice (GMP) requirements. At the end of the inspection, FDA inspectors record their observations regarding any processes or procedures that may, in their judgment, be out of compliance. These observations are noted on form FDA 483, List of Observations, so they are often called 483 reports. At the conclusion of the inspection, the inspectors discuss their observations with the manufacturer's management team.
What does it mean for a process to be Fully Verified?
A process is fully verified when it can be confirmed by a subsequent inspection or test. For a process to be confirmed, the verification activities (such as the inspection or test) and the results must be documented, signed and dated by the employee or employees approving the confirmation. For product design, procedures must be established and verified for each device’s specific design. Design verification must confirm that the final design of the device meets its previously defined design requirements. The results of design verification, including identification of the design and method(s), must be documented, signed and dated by the employee(s) approving the verification.
What does it mean for a test to be Adequately Validated?
Validated processes are shown by objective evidence to consistently produce a result or product that meets its pre-determined specifications. Validation must be performed by properly trained employees, and the monitoring, control methods and data, must be documented, signed and dated by the employee(s) performing the process. When changes or process deviations occur, the manufacturer must review and evaluate the process and perform revalidation where appropriate. These activities also must be documented.
What does it mean for a design to be Adequately Validated?
Validated designs are shown by objective evidence that the device specifications conform with the pre-defined user needs and the device’s intended use. Validation must be performed by properly trained employees, and the monitoring, control methods and data, must be documented, signed and dated by the employee or employees performing the process. When design changes occur, the manufacturer must review and evaluate the design change and perform revalidation where appropriate. These activities also must be documented.
What does it mean for a procedure to be Adequately Established?
Established means defining, documenting and implementing a specific activity or process. For a procedure to be adequately established, the manufacturer must have a procedure in place that has been defined and documented, and that procedure must be implemented and followed consistently. Any deviations from the procedure also must be documented.
What does it mean to have a Repeat Observation?
A repeat observation occurs when, on two successive investigations, FDA investigators observe continuing problems with the same quality system(s). Invacare received repeat observations at the corporate and Taylor Street facilities. Although we were addressing the issues identified by the FDA, we did not adequately resolve the Agency’s concerns. To rectify this, we are improving our quality and regulatory system to one led by managers with medical device and FDA experience. We have invested significantly in quality systems this year and hired a new Senior Vice President of Quality Assurance and Regulatory Affairs in December of 2011.
What are Non-Conforming Products?
A nonconforming product is one that did not meet at least one of the specified requirements regarding components, manufacturing materials, in-process devices, finished devices or returned devices.
What does it mean to have non-conforming products that are not Adequately Controlled?
Each product must have a control number or other distinctive symbol from which the history of its manufacturing, packaging, labeling and distribution can be traced.
As a manufacturer, Invacare must establish and maintain procedures to control product that does not conform to regulatory requirements. The procedures will address the identification, documentation, evaluation, segregation and disposition of non-conforming products. The evaluation of nonconformance will include determining the need to investigate and notify the organization responsible for the nonconformance. These evaluations and any investigations must also be properly documented.
What is a Corrective/Preventive Action?
Corrective actions and preventive actions (also called CAPAs, or corrective action / preventive action) are improvements to an organization's processes that are designed to eliminate causes of non-conformities or other undesirable situations. CAPAs focus on investigating the root causes of non-conformities and identifying ways to prevent them from recurring.
Corrective actions are implemented in response to customer complaints, undesired levels of internal nonconformity, nonconformities identified during an internal audit or an adverse event identified in product and process monitoring. Preventive actions are implemented in response to the identification of potential sources of non-conformity.
What is an Adverse Event?
An adverse event is any harmful event that causes or is likely to cause harm to the human body associated with the use of a medical product by a patient.
What is a Standard Sampling Plan?
A standard sampling plan is a method of analyzing information collected through postmarket surveillance once a product is in use. A standard sampling plan can be requested by the FDA. After the postmarket surveillance plan is approved, the plan must be enacted as designed and all reports must be provided in a timely manner.
What is an MDR Report?
An MDR Report is a Medical Device Report. An MDR is required to be filed with the FDA when information is discovered that reasonably suggests a device has or may have caused or contributed to a death or serious injury or has malfunctioned in a way that would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.