In the pre-market approval (PMA) quality system, design control is essential. Manufacturers must establish and maintain procedures to control the design of devices to ensure compliance with specified design requirements. Design control involves establishing and maintaining a plan that describes design and development activities, and clearly assigns responsibilities. The design process must include risk analysis, determining design inputs and outputs, verifying that design outputs meet design inputs, conducting design reviews, confirming that the design meets user needs and intended uses, validating software used, converting the design into production specifications, controlling design changes during the design process, and documenting design control activities. PMA submissions must include a complete description of the manufacturer’s implementation of design controls, and historical design files must be provided for FDA inspection.
Production control also plays a crucial role in PMA submissions, and must include a detailed description of the manufacturing, processing, packaging, storage, and facility methods used for devices. Manufacturers include not only companies that manufacture devices, but also contract manufacturers who perform production operations. Contract manufacturers can provide production information relevant to their operations to be included in PMA submissions, or submit this information directly to the FDA.
Quality system inspections are conducted by the Office of Product Evaluation and Quality (OPEQ) to review the design and manufacturing information submitted in PMAs. Pre-approval inspections verify whether manufacturers comply with quality system requirements. Once the manufacturer has demonstrated compliance with regulatory requirements for design and manufacturing processes, and the facility is ready for inspection, inspection tasks are assigned. Inspections include evaluating the company’s claimed capabilities to design and manufacture devices, ensuring that the quality system meets regulatory requirements. The inspection process assesses the extent of the company’s formal quality system procedures and ensures that designs are correctly translated into specifications. Inspections cover all major subsystems, including management control, design control, corrective action (CAPA), and production control.
Therefore, in the pre-market approval process, strict adherence to and compliance with design control and production control are essential to ensure that device design and manufacturing comply with regulatory requirements, ultimately safeguarding product quality and safety.
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