Subpart A General Provisions
Subpart B Labeling
Subpart C Requirements for Manufacturers and Producers

Terms Used In 21 CFR Part 809 - In Vitro Diagnostic Products for Human Use

  • 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.
  • Attachment: A procedure by which a person's property is seized to pay judgments levied by the court.
  • 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.
  • 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.
  • 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.
  • Litigation: A case, controversy, or lawsuit. Participants (plaintiffs and defendants) in lawsuits are called litigants.
  • Oath: A promise to tell the truth.
  • 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.
  • 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.
  • Recess: A temporary interruption of the legislative business.
  • 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.
  • Testimony: Evidence presented orally by witnesses during trials or before grand juries.
  • Trial: A hearing that takes place when the defendant pleads "not guilty" and witnesses are required to come to court to give evidence.
  • Verdict: The decision of a petit jury or a judge.