As the name implies, combination products are therapeutic or diagnostic products that combine drugs, devices, and/or biological products.
- Regulatory Concerns for Combination Products. Based upon the product’s primary mode of action, the FDA’s Office of Combination Products (OCP) determines which FDA center would be the lead center for the product’s marketing.
Pediatric Extrapolation for Devices (PEDS)
Due to a relatively small and geographically diverse patient cohort, and to the difficulty of obtaining informed consent, pediatric clinical trials are difficult to perform. Extrapolation refers to leveraging existing data from controlled studies of adult devices to support an application in the pediatric patient population.
- Benefits of Extrapolation:
- Facilitates the process of obtaining a pediatric use claim
- Can result in more products being allowed for the pediatric patient population
- Enhances and encourages more development of pediatric devices
- Increases availability of medical devices with appropriate pediatric labelling, thus enhancing safety
- When Is Extrapolation Appropriate?
- Similarity exists between the adult population and the intended pediatric patient.
- Sufficient quality, with respect to study design and data analysis, has been exhibited in the adult study.
- Reasonable assurance can be made of safety and effectiveness.
- Additional Information Regarding Extrapolation:
- The FDA has sponsored a webinar on the subject. View or download PDF here.
- An FDA guidance paper is available to view or download here.