Risk Framework Initiative

1. Risk Framework Initiative Kimber C. Richter, M.D. Office of Compliance, CDRH, FDA November 6, 2014 1

2. What is the Framework? • A set of broad principles • FDA and stakeholders will develop • For assessing risks and weighing benefits vs. risks of medical devices • In compliance quality and post market safety situations

3. Purpose of theRisk Framework • Allow FDA and Industry to arrive at the same, optimized risk and benefit/risk determinations • Allow rapid assessment of and response to device safety and shortage issues • Optimize public health

4. The Risk Framework Scope • Medical Devices • Regulated by CDRH

5. Focus Will Include • FDA and Industry compliance and enforcement activities • Mostly post-market • Some Pre-Approval Inspections • Quality and safety issues • Assessing risks, prioritizing and managing issues

6. Scope of Risks Addressed • Clinical risk of injury to patients/users from defects or failure of marketed devices • In addition to baseline risks known and accepted for cleared/approved devices • Risks from lack of access to devices - First of Kind - Shortage from FDA or Industry action

7. Not Within Scope • Pre-market Review • QS risk management in device design or manufacture • Detailed implementation of specific compliance processes by FDA or industry • Academic review of risk theories and practice • Changes to Regulation

8. Intended Outcome • Updating, optimizing and harmonizing risk assessment processes for FDA and Industry • Incorporating updated risk thinking into FDA and Industry compliance activities • Supporting public health through safe marketed products and access to devices necessary for essential patient care

9. Time Frame? • Goal for completion of Risk Framework Initiative is 2 years • May include draft Publication Times • Does not include all implementation by FDA or Industry

10. Compliance Work • To protect and promote public health by evaluating, enhancing, and ensuring compliance with medical device laws, resulting in the availability of high-quality medical devices. • To take actions that enable maximum device safety and effectiveness.

11. Compliance Activities Involve Evaluation of Quality System, promotion and advertising, premarket review and human subject protection regulations

12. Compliance Activity Examples • Recalls • Shortage assessment/mitigation • Inspection of manufacturing sites, clinical studies, IRB’s • Pre-approval inspection review

13. Enforcement Activities Include • Import detention • Untitled letters • Warning letters • Seizures • Injunctions

14. How Will This Be Done?

15. FDA Steering Committee • Chair – Kimber Richter • Senior Center and ORA management • Global Operations representative • Communications expertise • Compliance Leadership - OC and OIR • Premarket clinical representative

16. Project Will Be Modular • Planning will occur step by step. • Each step will guide future plans. • Success at each phase will be necessary to proceed.

17. Major Steps Expected • Develop overarching Principles • Initial public input • Finalize Principles document • Focus on applying Principles in more detail to key activities 5. Stakeholder input along the way

18. Use of Existing Information We will draw from available risk information - Standards - Guidance documents - Published literature - Current FDA practices

19. Risk Principles Working Group Small Working Group convened by AAMI, with FDA and Industry Co-Chairs, to review existing information and propose a set of risk factors and principles for FDA, Industry and other stakeholders to use in determining risk, including the balance of risks and benefits.

20. Identify Factors and Principles • Summarize factors used to assess risk that will be relevant to post market safety and quality issues • Identify principles of risk assessment that may be suitable to this work

21. What Are These Factors? Factors are key aspects of the device, population or other element of the environment or situation that affect the frequency or severity of risk. These are things that should be considered in a risk assessment, in order to reach the best informed decision.

22. Examples of Factors: • Nature of the illness treated or diagnosed by the device • Intended use of the device • Location of device (ICU, clinic, home) • Age and health of user population • Single use or multiple use device

23. What are Principles? Principles are guiding statements that indicate how factors should be used or risk assessments should be conducted.

24. Examples of PrinciplesMight Include: • Frequency and severity of adverse health consequences should both be considered in assessing risk. • The possibility that reporting of adverse events is incomplete should be considered when estimating frequency.

25. This Working Group • Met on September 30 – October 1 • Reviewed and revised initial lists of factors and principles from existing documents • Is preparing a rough draft document • This draft will require substantial editing • Draft for initial review December 2014?

26. This Working Group • Has also begun to identify some areas where industry and FDA approaches to risk assessment are not always consistent • Has suggested some areas where regulatory clarification from FDA would be helpful

27. The Risk Principles WGIs Expected To: • Complete the draft Risk Principles document • Review public comments and finalize the document • Provide guidance on future working groups, topics, and outputs

28. Future Plans • Draft Risk Principles Document for Public Comment • Public Meeting – March 2015? • Working Groups on specific compliance activities providing more detail on risk assessment and benefit/risk processes • Implementation by FDA and Industry

29. Possible Results? • A harmonized Risk Factors and Principles document • More detailed insight on how FDA and Industry might apply Factors and Principles to specific compliance activities though guidance documents, examples and check lists, public review of policies, etc. • CDRH will look at current practices in light of Risk Factors/Principles and public feedback.

30. Possible Results Cont’d • FDA review and updating of some key compliance procedures to apply the harmonized risk and benefit/risk approaches • Industry review and updating of some key procedures to apply the harmonized approaches

31. Possible Results Cont’d • Increased transparency and increased understanding of expectations between FDA and Industry, leading to swift and enhanced responses to safety and shortage issues with medical devices • Benefits to patients and health care providers

32. What Can You Do Today? • Share your perspective on situations or activities where FDA, Industry and other Stakeholders appear to assess risk differently, or you believe that confusion exists currently • Share examples if you have them

33. What Can You Do In Future? • Review and comment on documents circulated for input • Share your ideas through public forums • Use the documents, ask FDA for clarification if your result does not match ours, and provide feedback on your experiences

34. Questions? Concerns? Recommendations?

35. Contacts • Kimber.Richter@fda.hhs.gov • Jennifer.Kelly@fda.hhs.gov