Regulatory Affairs Certification (RAC) Practice Exam

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What is the provision for manufacturing reports on device manufacturing specifications by unit, lot, and batch under Quality System Regulation?

Device Master Record
Device History Record
An annual report
Quality Audit Record

The correct answer is: Device History Record

The Device History Record (DHR) is designed to contain the production history and specifications of a specific medical device. Under the Quality System Regulation (QSR), the DHR must include details such as the device manufacturing specifications, which encompass information by unit, lot, and batch. This comprehensive documentation ensures that manufacturers can trace the production history of devices, verify that they adhere to specified requirements, and confirm their quality throughout the manufacturing process. In contrast, the Device Master Record (DMR) contains the overall specifications for a device, including design and production information but does not focus specifically on tracking production history for individual units or lots. An annual report typically summarizes product performance and experience over a year but does not require detailed manufacturing specifics by unit or batch. The Quality Audit Record relates to the results of internal audits and compliance checks rather than manufacturing specifications. Thus, the DHR's role as a detailed account of device manufacturing aligns perfectly with the question's requirement for tracking specifications by unit, lot, and batch.