Design master record design history file4/13/2023 (f) Design input means the physical and performance requirements of a device that are used as a basis for device design. (e) Design history file ( DHF) means a compilation of records which describes the design history of a finished device. (d) Control number means any distinctive symbols, such as a distinctive combination of letters or numbers, or both, from which the history of the manufacturing, packaging, labeling, and distribution of a unit, lot, or batch of finished devices can be determined. ![]() (c) Component means any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device. (b) Complaint means any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution. ![]() All definitions in section 201 of the act shall apply to the regulations in this part. (a) Act means the Federal Food, Drug, and Cosmetic Act, as amended (secs.
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