510(k) Best Practices - Combining Risk Management & Design Controls.pptx

1. 510(k) Best Practices : Combining Risk Management & Design Controls Presented By : Mary Vater

2. Roadmap [email protected] www.MedicalDeviceAcademy.com Slide 2 of 28 Begin DHF 510(k) Clearance Design Transfer Pilot Phase Release Phase Hazard Identification Risk Control Option Analysis Risk Assessment Risk Control Effectiveness Verification Risk Management Plan Request Pre-Sub Meeting Pre-Sub Meeting Begin 510(k) Submit 510(k) Development Phase Feasibility Phase Concept Phase 90+ Days 100 Days 75-90 Days

3. Design Control Requirements 21 CFR 820.30 a) Establish and maintain procedures to control design b) Design and Development Planning c) Design Input d) Design Output e) Design Review f) Design Verification g) Design Validation h) Design Transfer i ) Design Changes j) Design History File www.MedicalDeviceAcademy.com [email protected] Slide 3 of 28

4. According to 21 CFR 820.30, The design history file shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part. Design History File [email protected] www.MedicalDeviceAcademy.com Slide 4 of 28

5. 21 CFR 820.30 (g) Design Validation Design validation shall include software validation and risk analysis, where appropriate. ISO 14971:2007 Question: To what extent does the FDA accept ISO 14971 as the basis of Risk Management? Risk Management Requirements [email protected] www.MedicalDeviceAcademy.com Slide 5 of 28

6. Risk Management File [email protected] www.MedicalDeviceAcademy.com Slide 6 of 28

7. Product Development Timeline [email protected] www.MedicalDeviceAcademy.com Slide 7 of 28 Question: When do you need to begin initiating design controls?

8. Concept → Development Phase [email protected] www.MedicalDeviceAcademy.com Slide 8 of 28

9. Design Reviews should be conducted after establishment of the User Needs, then again after each the Design Inputs, Design Process, and Design Outputs. Should ensure that all hazards have been identified, and that all hazards are mitigated as far as possible. Design Review [email protected] www.MedicalDeviceAcademy.com Slide 9 of 28

10. Design Inputs [email protected] www.MedicalDeviceAcademy.com Slide 10 of 28

11. Question: What is the recommended method for determining device hazards? Question: How can you be sure that you have identified all hazards and harms associated with the device? What’s the best approach? Identifying Hazards [email protected] www.MedicalDeviceAcademy.com Slide 11 of 28

12. Failure Modes and Effects Analysis (FMEA) Fault Tree Analysis (FTA) Question : FMEA vs. FTA which one is better for DHF? Question: Is FMEA commonly used for Software Medical Devices? Hazard and Operability Study (HAZOP) Hazard Analysis and Critical Control Point Analysis (HACCP) Risk Traceability Matrix Risk Analysis Tools [email protected] www.MedicalDeviceAcademy.com Slide 12 of 28

13. Risk Assessment [email protected] www.MedicalDeviceAcademy.com Slide 13 of 28

14. Question: Is it acceptable to take a risk occurrence reduction if labeling is used as an initial risk control? Question: When designing new technologies, what is the best method to minimize risk? Risk Reduction [email protected] www.MedicalDeviceAcademy.com Slide 14 of 28

15. Input Output Verification Validation [email protected] www.MedicalDeviceAcademy.com Slide 15 of 28 Question: What is the best design traceability method for tracking multiple design input sources (including risk) to design outputs? Question: Are there any software programs that you would recommend for design controls and risk management? User Need 1 Link to HA Design Input 1 Design Output 1 Verification Test Method Validation Test Method Link to HA Design Input 2 Design Output 2 Verification Test Method N/A Design Input 3 Design Output 3 Verification Test Method User Need 2 Link to HA Design Input 4 Design Output 4 Verification Test Method Validation Test Method Link to HA Design Input 5 Design Output 5 Verification Test Method User Need 3 N/A Design Input 6 Design Output 6 Verification Test Method Validation Test Method N/A Design Input 7 Design Output 7 Verification Test Method Link to HA Design Input 8 Design Output 8 Verification Test Method

16. Testing to Identified Standards Special Controls Guidance Documents Performance Testing for Essential Requirements/Principles Review Previous Submissions Testing to ensure hazards were adequately mitigated Process Validations Using Design Controls and Risk Management to Create Your Test Plan [email protected] www.MedicalDeviceAcademy.com Slide 16 of 28

17. [email protected] www.MedicalDeviceAcademy.com Slide 17 of 28 Pilot → Release Phase

18. Question: What is the difference between verification and validation? Question: Can the risk control effectiveness verification be performed at earlier phase of new product development than the pilot phase? Question: For software as a medical device, how much emphasis is placed on reviewing verification activities during the 510(k) submission? Verifying Effectiveness [email protected] www.MedicalDeviceAcademy.com Slide 18 of 28

19. Question: Is there a role for a stand-alone risk-benefit analysis in a 510(k)? Question: Is a stand-alone document for risk-benefit analysis required? Or should it be part of the Risk Management Plan or Clinical Evaluation Report? Risk-Benefit Analysis [email protected] www.MedicalDeviceAcademy.com Slide 19 of 28

20. Question: What risk documents should be included in a 510(k)? Risk in 510(k) Submission [email protected] www.MedicalDeviceAcademy.com Slide 20 of 28 Risk Management File FDA Submission Risk Management Plan N/A Hazard Identification Software Only Risk Assessment Software and Certain Special Controls Guidance Risk Control Option Analysis Software and Certain Special Controls Guidance Risk Control Verification Sections 14-18/20 Risk Control Validation Sections 14-18/20 Risk Benefit Analysis DeNovo Submissions, Humanitarian Device Exemptions, PMAs Informing Users and Patients of Risks Labeling Section 13 (warnings, contraindications, and precautions) Risk Management Report N/A

21. Question: What if any part of the DHF will be submitted with the 510(k)? Question: What DHF and risk documents should be included in a Special 510(k)? DHF in 510(k) Submission [email protected] www.MedicalDeviceAcademy.com Slide 21 of 28 DHF 510(k) Submission Design Plan N/A Inputs Form 3514, DoC Form3654 Outputs Section 11 Verification Sections 14-18/20 Validation Sections 14-18/20 Reviews N/A Design Release After 510(k) Clearance

22. Question: How should one apply risk management principles when the FDA asks for additional data or tests during the 510(k) review? FDA Review [email protected] www.MedicalDeviceAcademy.com Slide 22 of 28

23. Risk Life Cycle [email protected] www.MedicalDeviceAcademy.com Slide 23 of 28

24. Post Market Surveillance [email protected] www.MedicalDeviceAcademy.com Slide 24 of 28 ISO 14971 Figure E.1 – Pictorial representation of the relationship of hazard, sequence of events, hazardous situation, and harm.

25. Using Risk Assessment to Determine when a new 510(k) is required in the Design Process [email protected] www.MedicalDeviceAcademy.com Slide 25 of 28 Deciding When to Submit a 510(k) for a Change to an Existing Device – Draft Guidance for Industry and FDA Staff

26. Question : Are there software program to mange the design control/risk management? Question: How do you get management buy-in on risk as part of the design process, rather than a simple hazard analysis further down the road, say, as a checkbox for commercialization? General Questions [email protected] www.MedicalDeviceAcademy.com Slide 26 of 28

27. [email protected] www.MedicalDeviceAcademy.com Slide 27 of 28 Deadline Extended to Aug. 18th

28. Questions / Contact [email protected] www.MedicalDeviceAcademy.com Slide 28 of 28 Rob Packard, President/Consultant Email: [email protected] Phone: [phone] Mary Vater, Regulatory Consultant Email: [email protected] Phone: [phone] https://calendly.com/13485cert/15min www.MedicalDeviceAcademy.com