Terumo Cardiovascular Group

About Terumo CVS' Consent Decree

Glossary of Relevant Terms

Adulterated Product - Refers to products manufactured under a Quality System that is not compliant with FDA regulation.  Specifically, the term refers to products that may have been manufactured, packed, stored or installed using methods that did not fully conform with Current Good Manufacturing Practice (cGMP) for medical devices.

Also, in the case of Terumo CVS’ consent decree, the terms “adulterated product” and “misbranded product” do not imply that Terumo CVS products themselves have been found to be deficient.

CAPA - An abbreviation for Corrective Action and Preventive Action. 

  • Corrective Action - an action taken to prevent the recurrence of an existing nonconformity, defect, or other undesirable situation.
  • Preventive Action - an action taken to prevent the occurrence of a potential nonconformity, defect or other undesirable situation.

Complaint  [Product Complaint] - A written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety or performance of a medical device that has been placed on the market.

Consent Decree - A legal agreement approved by a judge.  In the medical device industry, a consent decree is an agreement between the FDA and a device manufacturer that defines the terms under which the company can continue to conduct business while it addresses FDA's concerns.

Corrective Action - An action taken to prevent the recurrence of an existing nonconformity, defect, or other undesirable situation.

Food And Drug Administration (FDA) - An agency within the Department of Health and Human Services that is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the nation’s food supply, cosmetics, and products that emit radiation, and by regulating the manufacture, marketing, and distribution of tobacco products.

FDA Form 483 - An FDA document listing observations of deficiencies noted by the FDA representative(s) during an inspection of a facility.

Disgorgement - A possible term in a consent decree.  It is a remedy imposed by the courts that requires a company to relinquish profits.  A disgorgement is not a penalty.  

Injunction - A court order that requires a company or person to do or refrain from doing certain acts.

Medical Device Reporting (MDR) - Medical Device Reporting is the mechanism for the FDA to receive reports of adverse events about medical devices from manufacturers, importers and user facilities, so they can be detected and corrected quickly.

Medical Necessity - A product used to treat or prevent a serious disease or medical condition for which there is no other available source considered by medical staff to be an adequate substitute, or for which the use of a substitute product would somehow create medical risk.

Misbranded Product - Refers to products that are labeled with false or misleading information, are misrepresented in promotional material, or otherwise violate the Misbranded Drug and Device Regulation.  In the case of Terumo CVS’ consent decree, Terumo CVS products are considered misbranded because the company did not furnish sufficient information to satisfy the requirements of the Medical Device Reporting (MDR) regulation.

Also, in the case of Terumo CVS’ consent decree, the terms “adulterated product” and “misbranded product” do not imply that Terumo CVS products themselves have been found to be deficient.

Preventive Action - An action taken to prevent the occurrence of a potential nonconformity, defect or other undesirable situation.

Quality System (or Quality Management System) - The organizational structure, processes and procedures that are created to assure compliance with Quality System Regulation. 

Quality System Regulation (QSR) - A compilation of requirements for medical device manufacturers published by FDA and Code of Federal Regulations (QSR Title 21 Part 820) for methods, facilities and controls that must be used to manufacture, package, store, and install finished medical devices intended for human use.  The intent of the QSR is to assure the safety and efficacy of medical devices.

Recall - A recall is an action taken by a medical device manufacturer to address a problem with a medical device when it is found to be defective, when it could be a risk to health, or when it is both defective and a risk to health.  A recall is either a correction or a removal depending on where the action takes place.

  • Correction - Addresses a problem with a medical device in the place where it is used or sold.  A Safety Advisory, in which a manufacturer addresses the problem with a device by informing users about it but does not intend to physically repair it, is considered a correction.
  • Removal - Addresses a problem with a medical device by removing it from where it is used or sold.

Warning Letter - An advisory to a company that communicates the FDA’s position on a matter.  A warning letter indicates that the agency may take enforcement action but does not commit the agency to do so.