Industry stakeholders told FDA that they want to see more clarity on its guidance on combination product premarket reviews.
Issued in February, the draft guidance explained how FDA centers would make approval pathway decisions for drug-device combination products.
The FDA considers that if a product’s primary mode of action is a device, then the product would be submitted under a medical device pathway with CDRH; whereas a product with a drug primary mode of action would be submitted under a drug pathway with CDER or CBER.
AdvaMed said the draft guidance was too general in parts and that the FDA should clarify that product centers have responsibility and authority for product-specific premarket decisions. AdvaMed flagged several examples of inconsistency in the guidance and asked the agency to “qualify its generalization with the caveat that center staff have authority for premarket review decisions, and they make these decisions on a case-by-case basis.”
The association said the guidance should also include a pathway for the use of a device master file for combination products. It said it is not uncommon for drug companies to partner with device companies for containers or delivery devices for drug or biologic products, and a medical device master file “provides a mechanism for the device company to maintain trade secrets or confidential commercial information.”