What type of product configuration is recommended for Combination Products?

If the PMOA Product is a single device constituent, then the product can be configured as per the steps suggested in the single entity combination products.

However, if there is a requirement to perform assessment of vaccine and devices separately in the case then it is recommended to configure the PMOA and device constituents under different products.

If the PMOA Product has a multiple device constituents, then the product can be configured as per steps suggested in the co-packaged combination products.