FDA’s Center for Devices and Radiological Health’s State of the Union 2021 Jeff Shuren, MD, JD Center for Devices and Radiological Health U.S. Food and Drug Administration www.fda.gov

Disclosure Statement of Financial Interest Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Company Grant/Research Support Consulting Fees/Honoraria Major Stock Shareholder/Equity Royalty Income Ownership/Founder Intellectual Property Rights Other Financial Benefit Company Names

In 2009, industry argued that FDA regulation hindered innovation and contributed to the growing number of device companies seeking marketing authorization for their devices abroad before introducing them in the United States and the increasing gap between when a device is approved in another country and when it is approved in the US. This reality, its adverse impact on patients, plus CDRH’s own awareness of our declining performance over almost a decade, led CDRH to implement new programmatic changes. These changes, along with increased user fee funding and changes in federal law, have helped us to change course, strengthen our performance, and better address the rapidly evolving field of medical device innovation. www.fda.gov

Vision We face a critical public health challenge The U.S. regulatory standard for market approval protects patients by setting a high public health bar but imposes costs that make the U.S. marketplace less attractive for innovators thereby delaying patient access to important technologies The solution is to reduce the time and cost of the total product life cycle… device development, assessment, review, manufacturing, monitoring, and reimbursement – without compromising the reasonable assurance of safety and effectiveness standard Vision “Patients in the U.S. have access to high-quality, safe and effective medical devices of public health importance first in the world.” www.fda.gov

Patient-Centered, TPLC Approach Benefit-Risk Tradeoffs Flexible Regulatory Paradigms Applied Across the Total Product Life Cycle CDRH Vision Patient-Centered, TPLC Approach Benefit-Risk Tradeoffs PMA, De Novo Benefit-Risk Determination Framework Guidance (2012) Postmarket Benefit-Risk Guidance (2016) Evidence Generation Premarket-Postmarket Balance Science of Patient Input Clinical Trials Regulatory Science Real-World Evidence Early Feasibility Study Paradigm Guidance (2013) Bayesian Statistics (2010), Adaptive Trial Design (2016) Guidances RWE Draft Guidance (2016) Expedited Access Pathway Program (2015) Patient Preference Information Guidance (2016) IDE Benefit-Risk Determination Framework Guidance (2017) Unique Device Identification Final Rule (2013) Balancing Premarket and Postmarket Data Collection Guidance (2015) Medical Device Innovation Consortium (MDIC) Patient Centered Benefit-Risk Project MDDT Pilot Program www.fda.gov NEST MDIC

In 2021 … www.fda.gov

CDRH is a Technology Enabler CDRH regulates only when value added CDRH designs flexible regulatory paradigms around the needs of the technology, patients, and providers CDRH routinely considers the societal benefit-risk trade-offs in all of our decision making www.fda.gov

Patients Are CDRH’s Partner Patients and CDRH routinely collaborate Clinical trials are designed around the needs and lifestyle of patients Clinical trials measure what matters most to patients CDRH routinely incorporates the perspectives and preferences of patients into our decision making www.fda.gov

Evidence Requirements Are Routinely Established and Updated Through Clinical Collaboratives www.fda.gov

CDRH is a Gateway to, Not a Gatekeeper of, Valid Scientific Information www.fda.gov

NEST is Fully Operational Robust real-world data is routinely and systematically gathered, analyzed, and used to inform CDRH decision making Clinical research starts to become incorporated into the workflow of routine clinical practice www.fda.gov

Device Companies Compete On Technology Safety and Quality Device companies and their technologies are publicly rated on safety and quality www.fda.gov

Evidence Generation, Evidence Evaluation, and Device Oversight are Global Enterprises www.fda.gov

International Medical Device Regulators Forum Unique Device Identification National Competent Authority Report Exchange Program Regulated Products Submission Adverse Event Reporting Device Registries Software as a Medical Device Medical Device Single Audit Program Premarket Review Meaningful harmonization would likely require the voluntary reliance on safety and performance principles or standards for 510(k)s and the voluntary participation in a progressive approval pathway for PMAs and de novos www.fda.gov

CDRH is an Integrated Total Product Life Cycle Organization CDRH reorganizes to integrate premarket, postmarket, and compliance activities, and to combine our clinical trial and real-world data efforts into a clinical evidence program “Premarket” and “postmarket” become obsolete concepts www.fda.gov

Example www.fda.gov

An Agile and Learning Paradigm for Software as a Medical device (SaMD) Clinical Trials Regulatory Science Real-World Evidence NEST Outcomes research Patient Preference Progressive Approval, Safety and Performance Premarket-Postmarket Balance Assurance Program FDA Learn DH Program FDA Pre✔ Bakul www.fda.gov

Learning Medical Device Ecosystem Total Product Life Cycle (TPLC) Framework EVOLUTION OF BENEFIT–RISK EVIDENCE INFORMATION FLOW Premarket Decision Progressive Approval, Safety and Performance NEST Expedited Access Pathway Real-World Evidence National Evaluation System (NEST) Premarket Review Postmarket Surveillance Patient Access Clinical Research Incorporated Into Routine Clinical Practice Benefit -Risk “Safety Net” Benefit-Risk TIME TO MARKET INTERNATIONAL HARMONIZATION

Thank You www.fda.gov