scope:

Inclusions

This TIR provides recommendations on the application of risk management principles and processes during development and marketing of combination products that include a device constituent part (drug−device, biological drug−device, or drug−device−biologic), in accordance with FDA's final rule (21 CFR Part 4) [11].⁴ These recommendations are intended to inform the adoption and application of established risk management processes during all phases of the lifecycle of combination products.

The recommendations and processes described in this TIR are intended to assist manufacturers of combination products in identifying hazards associated with the combination product, assessing associated risks, selecting options for controlling these risks, and monitoring the effectiveness of the implemented controls.

Exclusions

The TIR does not address drugs, biologics, or devices that are not part of a combination product, nor does it address drug−biologic combination products as risk management considerations for these are similar to those for drugs or biologics alone. Additionally, the TIR also does not address topics outside the realm of risk management for combination products. Finally, while the TIR might inform risk management practices for combination products marketed outside the United States, it is not intended, nor considered, to address non-U.S. practices or recommendations in all risk management considerations in a comprehensive fashion.

⁴ Among other things, Part 4 requires combination product manufacturers to comply with design control requirements, including requirements for risk management, consistent with 21 CFR 820.