Investigational combination products that include a device constituent part are subject to which provision of 21 CFR part 820?

Investigational combination products that include a device constituent part must adhere to the Design Controls specified in 21 CFR 820.30. This section is critical because it requires manufacturers to establish and maintain a design control process that ensures the safety and effectiveness of the device component being developed. It encompasses various stages of product development, including design planning, input, reviews, verification, validation, and design transfer, all of which are essential for regulatory compliance when assessing the combination product.

Adopting these design controls helps to ensure that both the drug and device components of the investigational combination product meet the intended specifications and regulatory requirements. By following these regulations, the developers can mitigate risks associated with the technical and regulatory challenges present in combination products. This adherence is fundamental in the clinical development phase to ensure that the combination product is both safe for human use and functionally viable as intended.

Other provisions such as quality system regulations, product quality assurance, and labeling requirements apply in broader contexts, but specific compliance with design controls is essential for successfully navigating the complexities of combination products that contain a device component.