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Tidepool's FDA Precertification Journey - #DData18


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Howard Look describes the journey of working with FDA on the new mHealth Pre certification program at the June 2018 DiabetesMine D-Data ExChange in Florida.

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Tidepool's FDA Precertification Journey - #DData18

  1. 1. Our Regulatory Journey, the FDA PreCert Program, and You. DiabetesMine D-Data ExChange June 22, 2018, ADA Orlando
  2. 2. Phase 1: Learning
  3. 3. Open source. Nonprofit. Transparency.
  4. 4. Public Internet Icons: Tidepool Platform A Vibrant Ecosystem
  5. 5. Laws Regulations Guidance Documents
  6. 6. Law: 21 USC § 301 Food, Drug and Cosmetic Act
  7. 7. Regulations: 21 CFR Part 11 21 CFR 803 21 CFR 820
  8. 8. 21 CFR 820.30 - Design Controls (e) Design review. Each manufacturer shall establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device's design development. The procedures shall ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed and an individual(s) who does not have direct responsibility for the design stage being reviewed, as well as any specialists needed. The results of a design review, including identification of the design, the date, and the individual(s) performing the review, shall be documented in the design history file (the DHF).
  9. 9. Phase 2: Challenge the Status Quo
  10. 10. Trello
  11. 11. Traceability
  12. 12. CircleCI
  13. 13. Agile processes + Modern tools = Iteration FTW!
  14. 14. FDA = Awesomesauce Courtney Lias and Stayce Beck Alain Silk Jisun Yi Yiduo Wu Naomi Schwartz Joshua Balsam Alain Silk Seth Carmody Brendan O’Leary Beth Stephen Bakul Patel Martin Ho Marisa Cruz Catharine Bahr John Murray Franscisco Vicenty Vizma Carver Linda Ricci Adam Berger Maggie Fu Ester Bleicher Diane Mitchell
  15. 15. MMA - Mobile Medical App Guidance MDDS - Medical Device Data Systems “Enforcement Discretion”
  16. 16. 21st Century Cures Act “Decision Support Software” Section 520(o)(1) of the FD&C Act (21 U.S.C. 360j(o)(1)(A)-(D)) 
 as added by Section 3060(a) of the 21st Century Cures Act “Information Blocking”
  17. 17. July, 2017: FDA Pre-certification Pilot Program
  18. 18. “FDA’s traditional approach for the regulation of hardware- based medical devices is not well- suited for the faster, iterative design and development, and type of validation” “An agile regulatory paradigm is necessary to accommodate the faster rate of development and potential for innovation in software-based products."
  19. 19. “When it comes to software, we think iteration is better for public health.” - Bakul Patel, FDA
  20. 20. Phase 3: Take Action
  21. 21. ✔ Patient Safety ✔ Product Quality ✔ Clinical Responsibility ✔ Proactive Culture ✔ Cybersecurity Responsibility Culture of Quality and Organizational Excellence Excellence Principles:
  22. 22. GitHub
  23. 23. Travis CI
  24. 24. Zeplin
  25. 25. Ghost
  26. 26. Rollbar
  27. 27. HelpScout
  28. 28. User Feedback Overview
  29. 29.
  30. 30. Risk Management
  31. 31. Key components: Excellence Appraisal and Precertification 
 Review Pathway Determination Streamlined Premarket Review Process 
 Real-World Performance
  32. 32.
  33. 33. “FDA intends to continue reviewing the public docket approximately every two weeks, and to refine this program by incorporating, as appropriate, comments in future versions of the working model. We encourage the public to provide feedback early and often. We request comments on each working model iteration no later than 30 days after the version posting.”
  34. 34. Step 1: Learn
  35. 35. Step 2: Challenge the Status Quo
  36. 36. Step 3: Take Action (No Excuses!)