Traceability. Each manufacturer of a device that is intended for surgical implant into the body or to support or sustain life and whose failure to perform when properly used in accordance with instructions for use provided in the labeling can be reasonably expected to result in a sig- nificant injury to the user shall estab- lish and maintain procedures for iden- tifying with a control number each unit, lot, or batch of finished devices and where appropriate components. The procedures shall facilitate correc- tive action. Such identification shall be documented in the DHR.
Appears in 10 contracts
Samples: Fda Regulations, Quality Management System Agreement, Quality Assurance Agreement
