Regulatory Affairs Certification (RAC) Practice Exam

For a medical device's storage and handling system, which of the following is NOT required by the manufacturer?

1. Separate rooms for release and quarantined material

2. Environmentally controlled areas for products

3. Procedures for rotation of stock

4. Procedures for shipping supplies

The correct answer is: Procedures for shipping supplies

The correct choice indicates that procedures for shipping supplies are not a requirement for the storage and handling system of a medical device as mandated by the manufacturer. In the context of regulatory requirements, the focus for a manufacturer typically centers on the control and management of products during storage and handling, which includes ensuring appropriate environments for product stability and effectiveness. Separate rooms for release and quarantined materials are necessary to prevent cross-contamination and to ensure that only approved products are available for distribution. Environmentally controlled areas are critical for maintaining the integrity of medical devices, particularly those sensitive to specific temperature or humidity conditions. Furthermore, procedures for rotation of stock, commonly known as "first in, first out" (FIFO), ensure that older stock is used before newer stock, which is essential for minimizing the risk of using expired or ineffective products. While effective shipping procedures may contribute to overall quality assurance, they are generally considered part of logistics and distribution rather than the core requirements for the storage and handling of medical devices. As such, the manufacturer may not be expressly required to outline shipping procedures within their storage and handling system.