Table 2 Additional 21 CFR Sections Applied to Combination Products with a Device Constituent
From: Stability considerations for drug-device combination products-21 CFR part 4 update
Section Title | Summary of Section Content |
|---|---|
21 CFR 820.20 Management Responsibility | Requires management with executive responsibility (senior leadership) to be actively engaged in the oversight of the quality system. They are to establish and maintain an adequate organizational structure, establish key quality policies, and conduct a management review periodically to ensure that the QMS is effective |
21 CFR 820.30 Design Controls | Requires the design and development process to be fully documented in a design history file (DHF). For a drug-device combination product, design control activities confirm that there are no negative interactions between constituent parts and ensure that their combined use results in a combination product that is safe, effective, and performs as intended |
21 CFR 820.50 Purchasing Controls | Describes manufacturers’ requirements to evaluate, qualify, continuously monitor, and control suppliers of materials and components. One way to facilitate purchasing controls is having well-defined supplier purchasing agreements. Combination product manufacturers must also comply with the testing requirements under 21 CFR 211.84 (above) for drug components, product containers, and closures |
21 CFR 820.100 Corrective and Preventive Action | Requires device manufacturers to establish and maintain procedures for implementing corrective and preventive action (CAPA). Corrective action is taken in response to a specific event, nonconformance, or trend. It is intended to determine the root cause and prevent a recurrence while preventive action is taken to avoid the occurrence of a potential event, nonconformance, or trend. For combination products, the CAPA process should consider the implications of CAPA for all constituent parts and the entire combination product |
21 CFR 820.170 Installation | Requires the manufacturer of a device requiring installation to establish and maintain adequate installation and inspection instructions and test procedures (where appropriate). As the FDA indicated, “installed and services devices will rarely be constituent parts of such combination products. If they are constituent parts of a combination product, they are more likely to be separately manufactured and marketed as constituent parts of cross-labeled combination products (FDA 2015) |
21 CFR 820.200 Servicing | Requires each manufacturer to establish and maintain instructions and procedures to verify that the servicing meets the specified requirements. This only applies if the device has servicing as a specified requirement. In the case of combination devices, this will be similar to the comments above for 21 CFR 820.170 |