10725. DEVICE HISTORY RECORD

10725 DEVICE HISTORY RECORD 10725.1 Each manufacturer shall maintain Device History Records (DHRs). Each manufacturer shall establish and maintain procedures to ensure that DHRs for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this chapter. The DHR shall include, or refer to the location of, the following information: The dates of manufacture; The quantity manufactured; The quantity released for distribution; The acceptance records which demonstrate the device is manufactured in accordance with the DMR; The primary identification label and labeling used for each production unit; and (f) Any device identification(s) and control number(s) used. SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10725