I am planning a trial with diabetic patients to use our digital tablet-based Android app for helping to track/manage glucose, nutrition, medications, and fitness-related activities. It has been recommended by an ex-FDA colleague that I produce the following and submit it to FDA before proceeding with a small clinical trial:

  • A brief description of the device, and intended use statement, an indication statement, and identify a predicate and outline for the overall development plan, including verification and validation assessments

Are there any model documents for the above available through OpenFDA or other resources that may be helpful?

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While I am not part of the Open FDA team (I am a member of the community), I am pretty sure this is not part of the current Open FDA initiative which is at http://open.fda.gov.

If I were you, I would start at the following links:

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