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Benefit-Risk Guidance: Impact on FDA Decision-Making CRT 2013 CAPT Brian Lewis, MD, USPHS Implantable Benefit-Risk Guidance: Impact on FDA Decision-Making CRT 2013 CAPT Brian Lewis, MD, USPHS Implantable Electrophysiological Devices Branch Division of Cardiovascular Devices Office of Device Evaluation CDRH/FDA February 26, 2013

Brian Lewis, MD I have no real or apparent conflicts of interest to report. Brian Lewis, MD I have no real or apparent conflicts of interest to report.

Acknowledgements Randall Brockman, MD Elias Mallis Acting Chief Medical Officer Office of Device Evaluation Acknowledgements Randall Brockman, MD Elias Mallis Acting Chief Medical Officer Office of Device Evaluation Center for Devices and Radiological Health, FDA Director Division of Small Manufacturers, International and Consumer Assistance Office of Communication and Education Center for Devices and Radiological Health, FDA 3

Why do we need this Benefit-Risk Guidance? “This guidance § clarifies this process for Why do we need this Benefit-Risk Guidance? “This guidance § clarifies this process for industry, which will § provide manufacturers with greater predictability, consistency and transparency in FDA decisionmaking while § allowing manufacturers and the FDA to use a common framework for benefit-risk determinations, ”* Jeffrey Shuren, M. D. , J. D. CDRH Director *http: //www. fda. gov/News. Events/Newsroom/Press. Announcements/ucm 297411. htm 4

What does the Guidance apply to? • Premarket approval applications (PMAs) • De Novo What does the Guidance apply to? • Premarket approval applications (PMAs) • De Novo applications Note: Guidance does not apply to premarket approval notifications (510 ks) 5

What does this new Guidance do? § Summarizes factors the FDA considers when making What does this new Guidance do? § Summarizes factors the FDA considers when making the benefit-risk determination § Provides standardized method for making decisions and documenting in consistent manner § Also contains several hypothetical examples to illustrate the process § Appendices to the Guidance include the worksheet the FDA uses during review to summarize its analysis and sample worksheets based on hypothetical examples 6

What constitutes an “appropriate benefit-risk determination”? § Does not refer to device being “OK” What constitutes an “appropriate benefit-risk determination”? § Does not refer to device being “OK” to approve or clear § Utilizes consistent methods to conduct premarket reviews of benefit and risk § Considers both valid clinical and non-clinical data § Supported by data analysis which demonstrates whether or not probable benefits of a device outweigh probable risks § Includes completion of Worksheet for Benefit-Risk Determinations § Takes into consideration applicable factors described in the following slides 7

Factors FDA considers in assessing benefit § § Type of benefit(s) Magnitude of benefit(s) Factors FDA considers in assessing benefit § § Type of benefit(s) Magnitude of benefit(s) Probability a patient will experience benefit(s) Duration of benefit(s) 8

Factors FDA considers in assessing risk § Severity, types, number and rates of harmful Factors FDA considers in assessing risk § Severity, types, number and rates of harmful events associated with use of device, including: § Device-related serious adverse events § Device-related non-serious adverse events § Complications from procedures § Probability of a harmful event; Duration § Risk of false-positive or false-negative results for diagnostics 9

Additional factors FDA takes into account § § § Degree of certainty of benefits Additional factors FDA takes into account § § § Degree of certainty of benefits and risks of a device Risk mitigation Post-market data Patient tolerance for risk and perspective on benefit Availability of alternative treatments or diagnostics Novel technology addressing unmet medical need 10

Patient Tolerance for Risk & Perspective on Benefit § § Patients with serious disease, Patient Tolerance for Risk & Perspective on Benefit § § Patients with serious disease, advanced sx’s Permanent implant Mechanism of action unclear Data indicates – Improved symptoms – Increased mortality § Patient preferences survey 11

Novel Technology and Unmet Medical Need § Medically refractory condition – High morbidity and Novel Technology and Unmet Medical Need § Medically refractory condition – High morbidity and mortality § Permanent implant – Around vascular structures § Bench testing safety concern – Potential for damage/erosion into artery § Long-term animal study needed – Prior to clinical study or run concurrently? 12

Internal FDA Training § Premarket review staff received training prior to implementation § Periodic Internal FDA Training § Premarket review staff received training prior to implementation § Periodic “Grand Rounds” – ODE and OIR (previously OIVD) – Led by Chief Medical Officers – Discuss current PMA and de novo applications 13

Useful Links § This is a link to the guidance document. http: //www. fda. Useful Links § This is a link to the guidance document. http: //www. fda. gov/downloads/Medical. Devices/Device. Regu lationand. Guidance/Guidance. Documents/UCM 296379. pdf § This is a link to a CDRH Learn module. http: //fda. yorkcast. com/webcast/Viewer/? peid=bac 3 f 2698 df 14 fa 98388409 da 5 cba 6831 d 14

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Providing Industry Education and Assistance – CDRH Resources § CDRH Learn – Online Regulatory Providing Industry Education and Assistance – CDRH Resources § CDRH Learn – Online Regulatory Training Tool – Over 50 Medical device and Radiological Health modules – Video, Power. Point presentations available 24/7 (some Chinese / Spanish) – Certificate of completion upon passing post-tests – http: //www. fda. gov/Training/CDRHLearn/ § Device Advice – Online Regulatory Information Searchable by Topic – http: //www. fda. gov/Medical. Devices/Device. Regulationand. Guidance/ § Division of Small Manufacturers, International, and Consumer Assistance (DSMICA) – Live Regulatory Assistance – Technical Assistance for the Medical Device Industry – Available 8: 00 am – 5: 00 pm EST @ 800 -638 -2041 or 301 -796 -7100 – DSMICA@fda. hhs. gov 16

Thank You 17 Thank You 17