ABSTRACT
In Chapter 7, we discussed various challenges that can be faced and pitfalls to be avoided by companies developing and manufacturing combination products. We touched upon postlaunch and compliance challenges. In this chapter we will focus on postlaunch compliance requirements, including, but not limited to, requirements in the areas of postmarket surveillance, tracking and reporting, and postmarket changes. Certain concerns facing companies are indicated below:
How will the facility be registered? Will the company be required to comply with the drug good manufacturing practices (GMP), the device quality system regulations (QSR), or both? What type of vigilance reporting is required? adverse drug reports (ADRs), medical device reports (MDRs), or both? If a change is made to the device, what rules determine whether the Food and Drug Administration (FDA) must be notifi ed? Does the change need to be approved before implementation? What rules need to be followed on traceability, device tracking, and so forth? How is advertising and promotion going to be regulated?
