Resource Index for Innovators

A visual guide to a selection of FDA tools, engagement opportunities, and guidances available throughout the process of bringing medical device software to market.

FDA Resource Index for Digital Health Device Innovators - Tools, engagement opportunities and guidance to help you through all phases of the total product life cycle. Text description of this image follows below.

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Market Research & Ideation | Develop Regulatory & Quality Strategy

• Digital Health Policy Navigator
  Determine which software functions are the focus of FDA’s oversight
• Digital Health FAQs
  Get answers to frequently asked questions
• Device Advice
  Read regulatory information about medical devices and ask questions
• CDRH Learn
  Watch learning modules on medical device regulation
• Patient-Centered Development
  Learn how to include patients during medical device development
• Digital Health Inbox
  Get informal answers to your digital health policy questions

Feasibility & Risk Analysis | Develop Regulatory & Quality Strategy

• Medical Device Software Guidance Navigator
  Identify digital health guidances for your regulatory strategy
• Digital Health Guidances
  Get clarity on the FDA's regulation of digital health products
• Regulatory Science Tools
  Get support for medical device development
• Quality System & Good Manufacturing Practices
  Learn about requirements & standards
• Small Business Assistance
  Get support for small innovators and ask questions  

Design & Development / Verification & Validation | Early FDA Engagement (recommended) / Prepare Marketing Submission and/or Technical File

• Q-Submission Program
  Optional opportunity to request feedback and meetings for medical device submissions
  • Informational Meeting
  • Pre-Submission
• Request for Information 513(g)
  Request information about classification or requirements applicable to a device
• Predetermined Change Control Plan for AI/ML-Enabled Device Software
  Learn about supporting safety and effectiveness in AI-enabled devices that modify over time

Pre-Launch Preparation | Submit Application / FDA Review & Authorization

• Content of Premarket Submissions for Device Software Functions
  Get information regarding the recommended documentation for premarket submissions
• eSTAR Program
  Receive guidance through the process of preparing a comprehensive medical device submission with this interactive PDF form
• Types of Communication During the Review of Medical Device Submissions
  Review forms of formal communication and interactive review
• Early Orientation
  Engage with the FDA on marketing submissions for medical device software

Launch / Post-Launch Monitoring & Iteration | Post Market Management

• MedWatch
  Use our Safety Information & Adverse Event Reporting program for patients, healthcare professionals, and consumers
• Device Registration and Listing
  Register annually with the FDA
• Deciding When to Submit a 510(k) for a Software Change to an Existing Device
  Review the decision-making process
• Medical Device Recalls
  Stay informed on medical device recalls and early alerts 

Contact Us

Have questions or feedback about the Resource Index for Digital Health Innovators? Send us an email at digitalhealth@fda.hhs.gov.