The FDA published their final guidance on consultation for combination products

In the US, a combination product is defined as “a product comprised of any combination of a drug, device, and/or biological product.” They are assigned to a lead FDA agency based on the component providing the primary mode of action. This agency will regulate the premarket and postmarket activities.

This new guidance describes the processes available to sponsors (product developer, future marketing authorisation holders) for effective communication with the FDA before and during the assessment process as well as best practices.

The sponsors are requested to only submit questions that are specific and appropriate to the stage of development, with sufficient background information to allow FDA to provide feedback without the need to request additional information. The requests must be sent to the appropriate lead agency through the identified point of contact (even if the question relates to an issue for which the expertise resides with another expert centre).

The FDA commits to notify the sponsor of the FDA point of contact as soon as a submission has been accepted, to engage relevant expertise as needed and to provide a consolidated, aligned and reliable feedback.

There are 2 processes for requesting feedback from FDA on combination products issues:

  • An application-based mechanism; this is the preferred interaction mechanism for requesting feedback on scientific issues, study design, testing approaches, application preparation considerations or clarifying topics for which FDA has already published technical guidance.
  • A combination product agreement meeting (CPAM); this is appropriate for seeking agreement from FDA on an topic for which previous feedback under an application-based mechanism was not sufficient. It may be used to address requirements for marketing authorisation or postmarket modifications for example.

The guidance describes the process for requesting a CPAM, the different information requested in the submission and the responses expected from FDA for the different steps of the process.

The full guidance is available here