The early design and development file creates a usable record of the agreed product baseline. Its contents reflect the intended use, risk, development stage, quality system, and scope of the build.
For a mobile app prototype or MVP, the practical goal is direct: the product inputs, implemented software, risks, usability work, and tests should agree with one another.
Core contents
Six parts of the early file.
Product definition
Intended purpose, intended users, use environment, product boundaries, assumptions, and the milestone for the build.
Design inputs
Approved user needs, software requirements, workflow requirements, data needs, constraints, and acceptance criteria.
Design and architecture
Screen behavior, system architecture, data flow, software components, and implementation decisions for the agreed scope.
Risk and traceability
Risk inputs and traceability that connect approved inputs to the implemented software and its tests.
Usability engineering
Users, use environments, workflows, use-related risks, interface evaluations, findings, and resulting design changes.
Verification and release
Agreed tests, results, unresolved issues, version information, release records, and the completed handoff.
Software records
Build the software and its evidence together.
FDA's current device-software guidance describes information commonly generated during software development, verification, and design validation. Capturing that information while the app is being built reduces the gap between the software and the records used to explain it.
The exact records depend on the device software function and its documentation level. Cybersecurity, off-the-shelf software, interoperability, algorithms, connected systems, and other product characteristics can add project-specific work.
FDA and ISO 13485
Begin with the product and applicable requirements.
FDA's Quality Management System Regulation became effective on February 2, 2026 and incorporates ISO 13485:2016 by reference. ISO 13485 sets quality-management-system requirements for organizations involved in medical-device design and production.
An early-stage file can set the foundation for later development and premarket work. The finished records, reviews, verification, validation, and submission content are determined by the product, its regulatory path, and the manufacturer's quality system.
At handoff
The next team should be able to follow the build.
A useful handoff identifies the released app version, source repository, approved inputs, implemented features, traceability, test evidence, known issues, and remaining work. That gives the next development or regulatory team a clear starting point.