Combination Drug-Device Product Makers Get Clarity on FDA Review

The FDA will review pre-filled syringes and other drug-device combination products based on which component achieves the primary purpose of the product, the agency said in finalized guidance released Friday.

The guidance document outlines which office of the Food and Drug Administration will review each product and seeks to provide clarity on how the agency intends to classify certain combination items. It also aims to shed light on what device makers will need to submit in their applications for premarket review.

The recommendations build on the FDA’s commitment to address longstanding confusion over how the agency regulates products that have ...