Manufacturing - Devices

Manufacturing encompasses the broad process of creating medical products, which can differ significantly for pharmaceuticals/drugs, biologics/biosimilars, and medical devices. For devices, manufacturers are required to establish and adhere to quality systems (QS) to ensure that their products consistently meet relevant requirements and specifications as outlined in 21 CFR 820.

The Quality System (QS) regulation follows a similar comprehensive approach as the original Current Good Manufacturing Practices (cGMP) regulation. It covers various aspects, including methods, facilities, controls, design, manufacturing, packaging, labeling, storage, installation, and servicing of medical devices for human use. The QS regulation applies to both finished device manufacturers and accessory manufacturers intending to distribute medical devices commercially. This regulation also introduces preproduction design controls to align with global quality system requirements. Each manufacturer is responsible for establishing requirements for each device type or family to ensure their safety and effectiveness, and for creating methods and procedures that meet the quality system requirements. Even medical devices produced under an investigational device exemption (IDE) are not exempt from design control requirements under 21 CFR 820.30 of the QS regulation. The Office of Compliance (OC) within the Center for Devices and Radiological Health (CDRH) and the Office of Device Evaluation (ODE) will concurrently review QS information submitted in premarket submissions. Similarly, the Center of Biologics Evaluation and Research (CBER) regulates medical devices related to licensed blood and cellular products.

Additionally, the FDA requires registration of domestic and foreign companies (or establishments) that produce and distribute medical devices intended for use in the United States. These companies must also provide a list of all their commercially distributed devices and the activities performed on those devices at that establishment.