Combination product applicant(s).

Combination product applicant(s).

• A. The company that holds the application for each component
• B. The regulatory authority
• C. The marketing partner
• D. The company that holds the application for the combination product as a whole

Answer: (D)

A combination product is regulated under a single, integrated submission, so the entity that owns and submits that entire product for regulatory review is the applicant for the product as a whole. This means one company bears overall regulatory responsibility for the complete product—the data, labeling, manufacturing controls, and postmarket commitments—even if the individual components were developed by different entities. That holistic ownership ensures clear accountability and streamlined communication with the regulatory agency. The other options don’t fit because the regulator is the review authority, not the applicant; a marketing partner may be involved in commercialization but does not automatically hold the regulatory submission for the entire product; and having separate applications for each component would imply fragmented regulatory control, whereas a combination product is handled under a single, unified submission.

A combination product is regulated under a single, integrated submission, so the entity that owns and submits that entire product for regulatory review is the applicant for the product as a whole. This means one company bears overall regulatory responsibility for the complete product—the data, labeling, manufacturing controls, and postmarket commitments—even if the individual components were developed by different entities. That holistic ownership ensures clear accountability and streamlined communication with the regulatory agency.

The other options don’t fit because the regulator is the review authority, not the applicant; a marketing partner may be involved in commercialization but does not automatically hold the regulatory submission for the entire product; and having separate applications for each component would imply fragmented regulatory control, whereas a combination product is handled under a single, unified submission.