Terms Used In 21 CFR Part 814 - Premarket Approval of Medical Devices

• 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.
• 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.
• 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.
• Complaint: A written statement by the plaintiff stating the wrongs allegedly committed by the defendant.
• Contract: A legal written agreement that becomes binding when signed.
• 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.
• Discovery: Lawyers' examination, before trial, of facts and documents in possession of the opponents to help the lawyers prepare for trial.
• Dismissal: The dropping of a case by the judge without further consideration or hearing. ^Source:
• Docket: A log containing brief entries of court proceedings.
• 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.
• 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.
• 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.
• 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}
• Gift: A voluntary transfer or conveyance of property without consideration, or for less than full and adequate consideration based on fair market value.
• 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.
• Indian Tribe: as used in this part includes such other authorized Indian Tribe, inter-Tribal consortium, or Tribal organization. See 42 CFR 137.10
• Joint resolution: A legislative measure which requires the approval of both chambers.
• 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.
• 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}
• Liabilities: The aggregate of all debts and other legal obligations of a particular person or legal entity.
• Litigation: A case, controversy, or lawsuit. Participants (plaintiffs and defendants) in lawsuits are called litigants.
• 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.
• Outlays: Outlays are payments made (generally through the issuance of checks or disbursement of cash) to liquidate obligations. Outlays during a fiscal year may be for payment of obligations incurred in prior years or in the same year.
• 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.
• Personal property: All property that is not real property.
• Real property: Land, and all immovable fixtures erected on, growing on, or affixed to the land.
• Remand: When an appellate court sends a case back to a lower court for further proceedings.
• 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.
• 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.