Findings
The FDA has distinct engagement pathways depending on whether the product is a Standalone Digital Health Product or a Combination Product. The pathways are further categorized into Informal and Formal advice.
Informal Pathways include:
Digital Health Inquiry (Digital health inbox, DICE mailbox inquiry).
General Inquiry for combination products.
CDRH List & Learn.
Formal Pathways for digital health and combination products include:
513(g) request (for classification information).
Q-Submission Program (Pre-Submission, Submission Issue Request (SIR), Information meeting).
CDRH-payor connection (Early payor feedback program, Parallel review with CMS).
RFD/Pre-RFD process (Request for Designation).

Recommendations
Developers should use this map to identify the appropriate mechanism for seeking regulatory advice. The initial decision point is whether the engagement is related to the design, development, or deployment of a digital health product. Once the product type is identified, the map directs the user to the appropriate formal or informal path. The various mechanisms are used for different purposes, such as an Information meeting (to share information without expecting feedback) or a Pre-Submission program (for formal feedback on a planned product).

Regulatory Considerations
The pathways involve different Centers and Offices, including the Center for Devices and Radiological Health (CDRH), Centers for Medicare & Medicaid Services (CMS), and the Office of Combination Products (OCP). The FDA’s focus is on engagement pathways for digital health products. For information on developing digitally derived endpoints for drugs, developers are directed to the DiMe and CTTI guides. Engagement is related to design, development, or deployment of the product