Terms Used In 21 CFR Part 822 - Postmarket Surveillance

• Amendment: A proposal to alter the text of a pending bill or other measure by striking out some of it, by inserting new language, or both. Before an amendment becomes part of the measure, thelegislature must agree to it.
• Answer: The formal written statement by a defendant responding to a civil complaint and setting forth the grounds for defense.
• Appeal: A request made after a trial, asking another court (usually the court of appeals) to decide whether the trial was conducted properly. To make such a request is "to appeal" or "to take an appeal." One who appeals is called the appellant.
• Arrest: Taking physical custody of a person by lawful authority.
• Assets: (1) The property comprising the estate of a deceased person, or (2) the property in a trust account.
• Beneficiary: A person who is entitled to receive the benefits or proceeds of a will, trust, insurance policy, retirement plan, annuity, or other contract. ^{Source: OCC}
• Contract: A legal written agreement that becomes binding when signed.
• Damages: Money paid by defendants to successful plaintiffs in civil cases to compensate the plaintiffs for their injuries.
• Discovery: Lawyers' examination, before trial, of facts and documents in possession of the opponents to help the lawyers prepare for trial.
• Evidence: Information presented in testimony or in documents that is used to persuade the fact finder (judge or jury) to decide the case for one side or the other.
• Fraud: Intentional deception resulting in injury to another.
• Freedom of Information Act: A federal law that mandates that all the records created and kept by federal agencies in the executive branch of government must be open for public inspection and copying. The only exceptions are those records that fall into one of nine exempted categories listed in the statute. ^{Source: OCC}
• Indian Tribe: as used in this part includes such other authorized Indian Tribe, inter-Tribal consortium, or Tribal organization. See 42 CFR 137.10
• Interest rate: The amount paid by a borrower to a lender in exchange for the use of the lender's money for a certain period of time. Interest is paid on loans or on debt instruments, such as notes or bonds, either at regular intervals or as part of a lump sum payment when the issue matures. ^{Source: OCC}
• Interrogatories: Written questions asked by one party of an opposing party, who must answer them in writing under oath; a discovery device in a lawsuit.
• Jurisdiction: (1) The legal authority of a court to hear and decide a case. Concurrent jurisdiction exists when two courts have simultaneous responsibility for the same case. (2) The geographic area over which the court has authority to decide cases.
• Litigation: A case, controversy, or lawsuit. Participants (plaintiffs and defendants) in lawsuits are called litigants.
• notification of potential rupture: refers to the notification of, or observation by, an operator (e. See 49 CFR 192.635
• Oath: A promise to tell the truth.
• Obligation: An order placed, contract awarded, service received, or similar transaction during a given period that will require payments during the same or a future period.
• Oversight: Committee review of the activities of a Federal agency or program.
• Personal property: All property that is not real property.
• Precedent: A court decision in an earlier case with facts and law similar to a dispute currently before a court. Precedent will ordinarily govern the decision of a later similar case, unless a party can show that it was wrongly decided or that it differed in some significant way.
• Public law: A public bill or joint resolution that has passed both chambers and been enacted into law. Public laws have general applicability nationwide.
• Real property: Land, and all immovable fixtures erected on, growing on, or affixed to the land.
• Settlement: Parties to a lawsuit resolve their difference without having a trial. Settlements often involve the payment of compensation by one party in satisfaction of the other party's claims.
• Statute: A law passed by a legislature.
• Subpoena: A command to a witness to appear and give testimony.
• Testimony: Evidence presented orally by witnesses during trials or before grand juries.
• Tort: A civil wrong or breach of a duty to another person, as outlined by law. A very common tort is negligent operation of a motor vehicle that results in property damage and personal injury in an automobile accident.
• Transcript: A written, word-for-word record of what was said, either in a proceeding such as a trial or during some other conversation, as in a transcript of a hearing or oral deposition.
• Trial: A hearing that takes place when the defendant pleads "not guilty" and witnesses are required to come to court to give evidence.