- It is considered a medicinal product under MPD if used separately,
- It must be liable to act upon the body;
- It must demonstrate ancillary action.
Applicable approval pathway
· Pre-market approval pathway (PMA)
· De Novo Classification requests
· Pre-market Notification (510(k)) submissions
· New Drug Application (NDA)
· Abbreviated New Drug Application (ANDA)
· Biologics License Applications (BLAs)-under section 351(a)
· BLAs for biosimilar and interchangeable products- under section 351(k)
 US FDA. Combination Product Definition Combination Product Types. 2018
 Reis ME, Bettencourt A, Ribeiro HM. The regulatory challenges of innovative customized combination products. Frontiers in Medicine. 2022;9.
 US FDA. Principles of Premarket Pathways for Combination Products. 2022
 Tian J, Song X, Wang Y, Cheng M, Lu S, Xu W, Gao G, Sun L, Tang Z, Wang M, Zhang X. Regulatory perspectives of combination products. Bioactive Materials. 2022 Apr 1;10:492-503.