Terms Used In 21 CFR Part 870 - Cardiovascular Devices

• Adjourn: A motion to adjourn a legislative chamber or a committee, if passed, ends that day's session.
• Advice and consent: Under the Constitution, presidential nominations for executive and judicial posts take effect only when confirmed by the Senate, and international treaties become effective only when the Senate approves them by a two-thirds vote.
• Affidavit: A written statement of facts confirmed by the oath of the party making it, before a notary or officer having authority to administer oaths.
• Allegation: something that someone says happened.
• 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.
• Amortization: Paying off a loan by regular installments.
• Annuity: A periodic (usually annual) payment of a fixed sum of money for either the life of the recipient or for a fixed number of years. A series of payments under a contract from an insurance company, a trust company, or an individual. Annuity payments are made at regular intervals over a period of more than one full year.
• 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.
• Appellate: About appeals; an appellate court has the power to review the judgement of another lower court or tribunal.
• Appraisal: A determination of property value.
• Appropriation: The provision of funds, through an annual appropriations act or a permanent law, for federal agencies to make payments out of the Treasury for specified purposes. The formal federal spending process consists of two sequential steps: authorization
• 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.
• Attachment: A procedure by which a person's property is seized to pay judgments levied by the court.
• Attorney General: includes the Alien Property Custodian whose functions were transferred to the Attorney General pursuant to Executive Order 9788 (3 CFR 1943-1948 Comp. See 26 CFR 303.1-1
• Attorney-at-law: A person who is legally qualified and licensed to practice law, and to represent and act for clients in legal proceedings.
• Attorney-in-fact: A person who, acting as an agent, is given written authorization by another person to transact business for him (her) out of court.
• Bankruptcy: Refers to statutes and judicial proceedings involving persons or businesses that cannot pay their debts and seek the assistance of the court in getting a fresh start. Under the protection of the bankruptcy court, debtors may discharge their debts, perhaps by paying a portion of each debt. Bankruptcy judges preside over these proceedings.
• Baseline: Projection of the receipts, outlays, and other budget amounts that would ensue in the future without any change in existing policy. Baseline projections are used to gauge the extent to which proposed legislation, if enacted into law, would alter current spending and revenue levels.
• 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}
• Bequest: Property gifted by will.
• Charity: An agency, institution, or organization in existence and operating for the benefit of an indefinite number of persons and conducted for educational, religious, scientific, medical, or other beneficent purposes.
• Commissioner: means the Commissioner of Internal Revenue. See 26 CFR 303.1-1
• Common law: The legal system that originated in England and is now in use in the United States. It is based on judicial decisions rather than legislative action.
• Complaint: A written statement by the plaintiff stating the wrongs allegedly committed by the defendant.
• Continuance: Putting off of a hearing ot trial until a later time.
• Contract: A legal written agreement that becomes binding when signed.
• Conviction: A judgement of guilt against a criminal defendant.
• Corporation: A legal entity owned by the holders of shares of stock that have been issued, and that can own, receive, and transfer property, and carry on business in its own name.
• corporation: includes associations, joint-stock companies, and insurance companies. See 26 CFR 36.3121(l)(1)-1
• Counterclaim: A claim that a defendant makes against a plaintiff.
• Damages: Money paid by defendants to successful plaintiffs in civil cases to compensate the plaintiffs for their injuries.
• Decedent: A deceased person.
• Deed: The legal instrument used to transfer title in real property from one person to another.
• Dependent: A person dependent for support upon another.
• Deposition: An oral statement made before an officer authorized by law to administer oaths. Such statements are often taken to examine potential witnesses, to obtain discovery, or to be used later in trial.
• Devise: To gift property by will.
• Discovery: Lawyers' examination, before trial, of facts and documents in possession of the opponents to help the lawyers prepare for trial.
• Docket: A log containing brief entries of court proceedings.
• domestic: when applied to a corporation * * * means created or organized in the United States or under the law of the United States or of any State or Territory. See 26 CFR 36.3121(l)(1)-1
• Donee: The recipient of a gift.
• Donor: The person who makes a gift.
• Electronic funds transfer: The transfer of money between accounts by consumer electronic systems-such as automated teller machines (ATMs) and electronic payment of bills-rather than by check or cash. (Wire transfers, checks, drafts, and paper instruments do not fall into this category.) ^{Source: OCC}
• Embezzlement: In most states, embezzlement is defined as theft/larceny of assets (money or property) by a person in a position of trust or responsibility over those assets. Embezzlement typically occurs in the employment and corporate settings. ^{Source: OCC}
• engaged in trade or business in the United States: includes the managing and renting of real estate in the United States by an agent of the Attorney General or of the former owner duly authorized to execute rental agreements and to pay all taxes and charges incident to the repair and maintenance of such property, but does not include the mere renting or leasing of property under an agreement requiring the lessee or occupant to pay taxes and to make repairs or improvements. See 26 CFR 303.1-1
• Entitlement: A Federal program or provision of law that requires payments to any person or unit of government that meets the eligibility criteria established by law. Entitlements constitute a binding obligation on the part of the Federal Government, and eligible recipients have legal recourse if the obligation is not fulfilled. Social Security and veterans' compensation and pensions are examples of entitlement programs.
• Equitable: Pertaining to civil suits in "equity" rather than in "law." In English legal history, the courts of "law" could order the payment of damages and could afford no other remedy. See damages. A separate court of "equity" could order someone to do something or to cease to do something. See, e.g., injunction. In American jurisprudence, the federal courts have both legal and equitable power, but the distinction is still an important one. For example, a trial by jury is normally available in "law" cases but not in "equity" cases. ^{Source: U.S. Courts}
• Escrow: Money given to a third party to be held for payment until certain conditions are met.
• 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.
• Executor: A male person named in a will to carry out the decedent
• Fair market value: The price at which an asset would change hands in a transaction between a willing, informed buyer and a willing, informed seller.
• Fiduciary: A trustee, executor, or administrator.
• Fiscal year: The fiscal year is the accounting period for the government. For the federal government, this begins on October 1 and ends on September 30. The fiscal year is designated by the calendar year in which it ends; for example, fiscal year 2006 begins on October 1, 2005 and ends on September 30, 2006.
• Foreclosure: A legal process in which property that is collateral or security for a loan may be sold to help repay the loan when the loan is in default. ^{Source: OCC}
• foreign: when applied to a corporation * * * means a corporation * * * which is not domestic. See 26 CFR 36.3121(l)(1)-1
• Forgery: The fraudulent signing or alteration of another's name to an instrument such as a deed, mortgage, or check. The intent of the forgery is to deceive or defraud. ^{Source: OCC}
• former owner: means the owner immediately prior to vesting and any successor in interest by inheritance, devise, bequest, or operation of law, of such owner. See 26 CFR 303.1-1
• 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}
• Germane: On the subject of the pending bill or other business; a strict standard of relevance.
• Gift: A voluntary transfer or conveyance of property without consideration, or for less than full and adequate consideration based on fair market value.
• Grace period: The number of days you'll have to pay your bill for purchases in full without triggering a finance charge. ^{Source: Federal Reserve}
• Grantor: The person who establishes a trust and places property into it.
• Gross estate: The total fair market value of all property and property interests, real and personal, tangible and intangible, of which a decedent had beneficial ownership at the time of death before subtractions for deductions, debts, administrative expenses, and casualty losses suffered during estate administration.
• Guardian: A person legally empowered and charged with the duty of taking care of and managing the property of another person who because of age, intellect, or health, is incapable of managing his (her) own affairs.
• immigrant: means every alien except an alien who is within one of the following classes of nonimmigrant aliens—

  (F) (i) An alien having a residence in a foreign country which he has no intention of abandoning, who is a bona fide student qualified to pursue a full course of study and who seeks to enter the United States temporarily and solely for the purpose of pursuing such a course of study at an established institution of learning or other recognized place of study in the United States, particularly designated by him and approved by the Attorney General after consultation with the Office of Education of the United States, which institution or place of study shall have agreed to report to the Attorney General the termination of attendance of each nonimmigrant student, and if any such institution of learning or place of study fails to make reports promptly the approval shall be withdrawn, and (ii) the alien spouse and minor children of any such alien if accompanying him or following to join him;

  (J) An alien having a residence in a foreign country which he has no intention of abandoning who is a bona fide student, scholar, trainee, teacher, professor, research assistant, specialist, or leader in a field of specialized knowledge or skill, or other person of similar description, who is coming temporarily to the United States as a participant in a program designated by the Secretary of State, for the purpose of teaching, instructing or lecturing, studying, observing, conducting research, consulting, demonstrating special skills, or receiving training, and the alien spouse and minor children of any such alien if accompanying him or following to join him. See 26 CFR 31.3401(a)(6)-1A

• Indictment: The formal charge issued by a grand jury stating that there is enough evidence that the defendant committed the crime to justify having a trial; it is used primarily for felonies.
• Inter vivos: Transfer of property from one living person to another living person.
• 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}
• international organization: means a public international organization entitled to enjoy privileges, exemptions, and immunities as an international organization under the International Organizations Immunities Act (22 U. See 26 CFR 31.3306(c)(16)-1
• Intestate: Dying without leaving a will.
• Joint committee: Committees including membership from both houses of teh legislature. Joint committees are usually established with narrow jurisdictions and normally lack authority to report legislation.
• Judgement: The official decision of a court finally determining the respective rights and claims of the parties to a suit.
• 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.
• Lawsuit: A legal action started by a plaintiff against a defendant based on a complaint that the defendant failed to perform a legal duty, resulting in harm to the plaintiff.
• Lease: A contract transferring the use of property or occupancy of land, space, structures, or equipment in consideration of a payment (e.g., rent). ^{Source: OCC}
• Legacy: A gift of property made by will.
• Legatee: A beneficiary of a decedent
• Liabilities: The aggregate of all debts and other legal obligations of a particular person or legal entity.
• Lien: A claim against real or personal property in satisfaction of a debt.
• Litigation: A case, controversy, or lawsuit. Participants (plaintiffs and defendants) in lawsuits are called litigants.
• Markup: The process by which congressional committees and subcommittees debate, amend, and rewrite proposed legislation.
• Mortgage: The written agreement pledging property to a creditor as collateral for a loan.
• Mortgagee: The person to whom property is mortgaged and who has loaned the money.
• Mortgagor: The person who pledges property to a creditor as collateral for a loan and who receives the money.
• 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.
• Oral argument: An opportunity for lawyers to summarize their position before the court and also to answer the judges' questions.
• Oversight: Committee review of the activities of a Federal agency or program.
• Partnership: A voluntary contract between two or more persons to pool some or all of their assets into a business, with the agreement that there will be a proportional sharing of profits and losses.
• person: includes an individual, a trust, estate, partnership, company, or corporation, and any entity having or claiming an interest in vested property or liable or charged with liability for internal revenue tax in connection with such property. See 26 CFR 303.1-1
• Personal property: All property that is not real property.
• Plea: In a criminal case, the defendant's statement pleading "guilty" or "not guilty" in answer to the charges, a declaration made in open court.
• Pleadings: Written statements of the parties in a civil case of their positions. In the federal courts, the principal pleadings are the complaint and the answer.
• Power of attorney: A written instrument which authorizes one person to act as another's agent or attorney. The power of attorney may be for a definite, specific act, or it may be general in nature. The terms of the written power of attorney may specify when it will expire. If not, the power of attorney usually expires when the person granting it dies. ^{Source: OCC}
• 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.
• Presiding officer: A majority-party Senator who presides over the Senate and is charged with maintaining order and decorum, recognizing Members to speak, and interpreting the Senate's rules, practices and precedents.
• Probate: Proving a will
• property: includes money, the proceeds of property, income, dividends, interest, annuities, and other earnings, but does not include any property or interest or any of the foregoing which vested in the Attorney General or was otherwise acquired by the United States prior to December 18, 1941. See 26 CFR 303.1-1
• property vested in the Attorney General: include property conveyed, transferred, assigned, delivered, or paid to or held or controlled by or vested in the Attorney General, under the Trading With the Enemy Act. See 26 CFR 303.1-1
• Public law: A public bill or joint resolution that has passed both chambers and been enacted into law. Public laws have general applicability nationwide.
• Quorum: The number of legislators that must be present to do business.
• Real property: Land, and all immovable fixtures erected on, growing on, or affixed to the land.
• Recess: A temporary interruption of the legislative business.
• Recourse: An arrangement in which a bank retains, in form or in substance, any credit risk directly or indirectly associated with an asset it has sold (in accordance with generally accepted accounting principles) that exceeds a pro rata share of the bank's claim on the asset. If a bank has no claim on an asset it has sold, then the retention of any credit risk is recourse. ^{Source: FDIC}
• Remainder: An interest in property that takes effect in the future at a specified time or after the occurrence of some event, such as the death of a life tenant.
• Remand: When an appellate court sends a case back to a lower court for further proceedings.
• Reporter: Makes a record of court proceedings and prepares a transcript, and also publishes the court's opinions or decisions (in the courts of appeals).
• Rescission: The cancellation of budget authority previously provided by Congress. The Impoundment Control Act of 1974 specifies that the President may propose to Congress that funds be rescinded. If both Houses have not approved a rescission proposal (by passing legislation) within 45 days of continuous session, any funds being withheld must be made available for obligation.
• Service of process: The service of writs or summonses to the appropriate party.
• 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.
• Sole ownership: The type of property ownership in which one individual holds legal title to the property and has full control of it.
• Statute: A law passed by a legislature.
• Statute of limitations: A law that sets the time within which parties must take action to enforce their rights.
• stock: includes shares in an association, joint-stock company, or insurance company. See 26 CFR 36.3121(l)(8)-1
• Subpoena: A command to a witness to appear and give testimony.
• Summons: Another word for subpoena used by the criminal justice system.
• target value: means the overall mean after outlier removal (as defined above) unless acceptable scientific reasons are available to indicate that such an evaluation is not appropriate. See 42 CFR 493.2
• tax: has the meaning stated in section 36(d) of the Trading With the Enemy Act as added by the Act of August 8, 1946. See 26 CFR 303.1-1
• Testify: Answer questions in court.
• 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.
• Trading With the Enemy Act: includes all amendments of such Act, and all orders, rules, and regulations issued or prescribed under such Act or any such amendment. See 26 CFR 303.1-1
• 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.
• Trustee: A person or institution holding and administering property in trust.
• Uphold: The decision of an appellate court not to reverse a lower court decision.
• User fees: Fees charged to users of goods or services provided by the government. In levying or authorizing these fees, the legislature determines whether the revenue should go into the treasury or should be available to the agency providing the goods or services.
• Veto: The procedure established under the Constitution by which the President/Governor refuses to approve a bill or joint resolution and thus prevents its enactment into law. A regular veto occurs when the President/Governor returns the legislation to the house in which it originated. The President/Governor usually returns a vetoed bill with a message indicating his reasons for rejecting the measure. In Congress, the veto can be overridden only by a two-thirds vote in both the Senate and the House.