Adulterated Product: Products are deemed legally adulterated if they fail to meet the Quality System criteria of the FDA. Specifically, if a company is not following Current Good Manufacturing Practices (cGMPs) in manufacturing a product, the product is considered adulterated under law.
CAPA: An abbreviation for “Corrective and Preventive Action”.
Correction: Repairing, modifying, adjusting, relabeling, destroying or inspection (including patient monitoring) of a device without physical removal from its point of use to some other location.
Corrective Action: Actions taken to eliminate the causes of an existing nonconformity in order to avoid its recurrence.
Complaint [Product Compliant]: A verbal or written statement of dissatisfaction with the quality or performance of a product.
Consent Decree: A voluntary legal agreement that establishes a framework that provides assurances to FDA that the company will complete the improvements to its quality management system.
Injunction: A judiciary order that requires a party to do or cease doing specific acts.
Medical Necessity: A situation when there is no alternative or substitution for a product that is used to treat or prevent a serious disease or medical condition.
Misbranded Product: A product is considered misbranded if its labeling is false, misleading, does not bear adequate information, or is not consistent with the promotional material.
Preventive Action: Actions taken to eliminate the causes of a potential nonconformity.
Quality System (or Quality Management System): The structure, policies, procedures and process that organizations establish and follow to ensure their products meet the requirements and specifications of FDA regulations.
Quality System Regulation (QSR): FDA regulatory requirements for the design, manufacture, packaging, labeling, storage, installation and servicing of medical devices. These regulations are located in Code 21 of Federal Regulations Part 820
Removal: Taking a medical device away from where they are used or sold.