Skip to main content

New, free course on capturing the value of V1C for healthcare!

Join FDA and DiMe during a 2-day virtual event.

Federal Comment Toolkit

Optimizing Digital Medicine Regulations

When a Federal Agency issues regulations —also known as ‘rules’ — they solicit public input to the process. Whether an Agency is responding to a new law or simply seeking to clarify a position or process, they are legally bound to seek public input.
This can happen in two phases:
  • The Agency may open a public docket to seek early input.
  • Any new rule or changes to an existing rule must be posted in draft form for public comment.

Federal agencies are required to consider all public comments when preparing final rules, so the public comment is a powerful opportunity to affect regulatory procedure. In addition, when Congress considers new legislation, they typically put out a request for information (RFI).

Your insight matters

DiMe has established a process to collate regulations that impact our field of digital medicine. Our goal is to make it easy for our community of experts to share their insights and provide broad expert input to the next generation of digital regulation in healthcare.

  • Please view our lists, which are searchable by keyword, agency, sub-agency, and RIN number.

  • Ready to make your public comment? Check out our templates and examples.

  • Looking to collaborate on a public comment? Head to the DiMe Slack channel #federalcomment to find collaborators. 

Rulemaking stages

What is coming up for comment?

Search the list of upcoming federal regulations relevant to digital medicine. Filter by government branch, keywords, or rule-making stage.

Need help making your comment?

Check out previous comments or use one of our templates when you are ready to write your own comment.

Join our next project

Help streamline the path to regulatory and commercial success to optimize health outcomes for the greatest number of patients

Join the Integrated Evidence Plans project

Join us
Not today