§ 1271.1 What are the purpose and scope of this part?
§ 1271.3 How does FDA define important terms in this part?
§ 1271.10 Are my HCT/P’s regulated solely under section 361 of the PHS Act and the regulations in this part, and if so what must I do?
§ 1271.15 Are there any exceptions from the requirements of this part?
§ 1271.20 If my HCT/P’s do not meet the criteria in § 1271.10, and I do not qualify for any of the exceptions in § 1271.15, what regulations apply?

Terms Used In CFR > Title 21 > Chapter I > Subchapter L > Part 1271 > Subpart A - General Provisions

  • 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.
  • Dependent: A person dependent for support upon another.
  • Donor: The person who makes a gift.
  • 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.
  • 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
  • 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.