1. Utah Life Science Summit 2015 5 Nov. 2015 Phil Triolo, PhD RAC President, Phil Triolo and Associates LC

2. Overview One element of the FDA and all regulatory bodies) that is constant is change. This brief presentation will identify some of the major changes in FDA guidance and new initiatives that are relevant to medical device manufacturers. Details can be provided at future sessions, depending on interest/feedback. 2 FDA Update Phil Triolo Sr. Consultant Phil Triolo and Associates LC BioUtah Life Science Summit 5 Nov. 2015

3. Changes that have already been implemented (but you may be catching up…) UDI (Universal Device Identifier) Requirements http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidanc e/UniqueDeviceIdentification/ eMDR (electronic Medical Device Reporting) http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidanc e/PostmarketRequirements/ReportingAdverseEvents/eMDR%E2 %80%93ElectronicMedicalDeviceReporting/ucm2019327.htm pMAP (pilot Multipurpose Audit Program) http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidanc e/PostmarketRequirements/ThirdPartyInspection/ucm232806. htm 3 FDA Update Phil Triolo Sr. Consultant Phil Triolo and Associates LC BioUtah Life Science Summit 5 Nov. 2015

4. Changes that have already been implemented (but you may be catching up…) Cybersecurity http://www.fda.gov/MedicalDevices/DigitalHealth/uc m373213.htm Parallel Review http://www.fda.gov/NewsEvents/Newsroom/PressA nnouncements/ucm409021.htm http://www.fda.gov/AboutFDA/PartnershipsCollaborations/ MemorandaofUnderstandingMOUs/DomesticMOUs/ucm 217585.htm announcement 4 FDA Update Phil Triolo Sr. Consultant Phil Triolo and Associates LC BioUtah Life Science Summit 5 Nov. 2015

5. On the horizon- Significant Impact (when applicable) Lab Developed Tests (Moj will address these) http://blogs.fda.gov/fdavoice/index.php/2015/04/f da-and-cms-form-task-force-on-ldt-quality- requirements/ Patient Engagement Advisory Committees http://blogs.fda.gov/fdavoice/index.php/2015/09/f da-announces-first-ever-patient-engagement- advisory-committee/ 5 FDA Update Phil Triolo Sr. Consultant Phil Triolo and Associates LC BioUtah Life Science Summit 5 Nov. 2015

6. New Guidance Documents http://www.fda.gov/MedicalDevices/DeviceRegulationand Guidance/GuidanceDocuments/ucm418448.htm http://www.fda.gov/MedicalDevices/DeviceRegulationand Guidance/GuidanceDocuments/ucm418448.htm Global Unique Device Identification Database (GUDID): Data Submission Compliance Date of September 24, 2015 - Guidance for Industry and Food and Drug Administration Staff Global Unique Device Identification Database (GUDID): Data Submission Compliance Date of September 24, 2015 - Guidance for Industry and Food and Drug Administration Staff Unique Device Identification: Direct Marking of Devices - Draft Guidance for Industry and Food and Drug Administration Staff Unique Device Identification: Direct Marking of Devices - Draft Guidance for Industry and Food and Drug Administration Staff 6 FDA Update Phil Triolo Sr. Consultant Phil Triolo and Associates LC BioUtah Life Science Summit 5 Nov. 2015

7. New Guidance Documents Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements - Guidance for Industry and Food and Drug Administration Staff (updated list) Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements - Guidance for Industry and Food and Drug Administration Staff Refuse to Accept Policy for 510(k)s - Guidance for Industry and Food and Drug Administration Staff (new checklist) Refuse to Accept Policy for 510(k)s - Guidance for Industry and Food and Drug Administration Staff 7 FDA Update Phil Triolo Sr. Consultant Phil Triolo and Associates LC BioUtah Life Science Summit 5 Nov. 2015

8. New Guidance Documents Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions - Guidance for Industry and Food and Drug Administration Staff Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions - Guidance for Industry and Food and Drug Administration Staff Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval - Guidance for Industry and Food and Drug Administration Staff more post-mkt considerations Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval - Guidance for Industry and Food and Drug Administration Staff 8 FDA Update Phil Triolo Sr. Consultant Phil Triolo and Associates LC BioUtah Life Science Summit 5 Nov. 2015

9. New Guidance Documents Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment - Guidance for Industry and Food and Drug Administration Staff Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment - Guidance for Industry and Food and Drug Administration Staff Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications - Guidance for Industry and Food and Drug Administration Staff Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications - Guidance for Industry and Food and Drug Administration Staff 9 FDA Update Phil Triolo Sr. Consultant Phil Triolo and Associates LC BioUtah Life Science Summit 5 Nov. 2015

10. New Guidance Documents Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices - Guidance for Industry and Food and Drug Administration Staff Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices - Guidance for Industry and Food and Drug Administration Staff Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems - Guidance for Industry and Food and Drug Administration Staff Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems - Guidance for Industry and Food and Drug Administration Staff 10 FDA Update Phil Triolo Sr. Consultant Phil Triolo and Associates LC BioUtah Life Science Summit 5 Nov. 2015

11. New Draft Guidance Documents http://www.fda.gov/MedicalDevices/DeviceRegulationand Guidance/GuidanceDocuments/ucm418408.htm http://www.fda.gov/MedicalDevices/DeviceRegulationand Guidance/GuidanceDocuments/ucm418408.htm Current Good Manufacturing Practice Requirements for Combination Products Current Good Manufacturing Practice Requirements for Combination Products General Considerations for Animal Studies for Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff General Considerations for Animal Studies for Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff Draft Guidance for Industry and Food and Drug Administration Staff - Applying Human Factors and Usability Engineering to Optimize Medical Device Design Draft Guidance for Industry and Food and Drug Administration Staff - Applying Human Factors and Usability Engineering to Optimize Medical Device Design 11 FDA Update Phil Triolo Sr. Consultant Phil Triolo and Associates LC BioUtah Life Science Summit 5 Nov. 2015

12. New Draft Guidance Documents Homologous Use of Human Cells, Tissue, and Cellular and Tissue-Based Products; Draft guidance for Industry and FDA Staff Homologous Use of Human Cells, Tissue, and Cellular and Tissue-Based Products; Draft guidance for Industry and FDA Staff Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi- Configuration Passive Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi- Configuration Passive Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 325KB) Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 325KB) 12 FDA Update Phil Triolo Sr. Consultant Phil Triolo and Associates LC BioUtah Life Science Summit 5 Nov. 2015

13. New Draft Guidance Documents Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 1.1MB) Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 1.1MB) Adaptive Designs for Medical Device Clinical Studies - Draft Guidance for Industry and Food and Drug Administration Staff Adaptive Designs for Medical Device Clinical Studies - Draft Guidance for Industry and Food and Drug Administration Staff 13 FDA Update Phil Triolo Sr. Consultant Phil Triolo and Associates LC BioUtah Life Science Summit 5 Nov. 2015

14. New Draft Guidance Documents Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States - Draft Guidance for Industry and Food and Drug Administration Staff Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States - Draft Guidance for Industry and Food and Drug Administration Staff Procedures for Meetings of the Medical Devices Advisory Committee - Draft Guidance for Industry and Food and Drug Administration Staff Procedures for Meetings of the Medical Devices Advisory Committee - Draft Guidance for Industry and Food and Drug Administration Staff Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions - Draft Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators, and Food and Drug Administration Staff (PDF - 877KB) Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions - Draft Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators, and Food and Drug Administration Staff (PDF - 877KB) 14 FDA Update Phil Triolo Sr. Consultant Phil Triolo and Associates LC BioUtah Life Science Summit 5 Nov. 2015

15. New Draft Guidance Documents Patient Preference Information - Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Device Labeling - Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders Patient Preference Information - Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Device Labeling - Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing - Draft Guidance for Industry and Food and Drug Administration Staff Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing - Draft Guidance for Industry and Food and Drug Administration Staff 15 FDA Update Phil Triolo Sr. Consultant Phil Triolo and Associates LC BioUtah Life Science Summit 5 Nov. 2015

16. New Draft Guidance Documents General Wellness: Policy for Low Risk Devices - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 550KB) General Wellness: Policy for Low Risk Devices - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 550KB) Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 309KB) Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 309KB) 16 FDA Update Phil Triolo Sr. Consultant Phil Triolo and Associates LC BioUtah Life Science Summit 5 Nov. 2015

17. New Draft Guidance Documents Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices - Draft Guidance for Industry and Food and Drug Administration Staff Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices - Draft Guidance for Industry and Food and Drug Administration Staff Draft Guidance for Industry and FDA Staff - Premarket Notification [510(k)] Submissions for Medical Devices that Include Antimicrobial Agents Draft Guidance for Industry and FDA Staff - Premarket Notification [510(k)] Submissions for Medical Devices that Include Antimicrobial Agents Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing - Draft Guidance for Industry and Food and Drug Administration Staff Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing - Draft Guidance for Industry and Food and Drug Administration Staff 17 FDA Update Phil Triolo Sr. Consultant Phil Triolo and Associates LC BioUtah Life Science Summit 5 Nov. 2015

18. Looking Ahead- FDA’s 2015 Guidance Document “to do” list Final Guidance: Use of International Standard ISO- 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing“ (Thor Rollins wrote a 3-part article on the draft that is published in MDDI.) 18 FDA Update Phil Triolo Sr. Consultant Phil Triolo and Associates LC BioUtah Life Science Summit 5 Nov. 2015

19. Questions or Comments Feel free to contact me: Phil Triolo, PhD RAC Phil Triolo and Associates LC (philt@philt.com) or +1 801 699 9846 19 FDA Update Phil Triolo Sr. Consultant Phil Triolo and Associates LC BioUtah Life Science Summit 5 Nov. 2015