1. 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

2. 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

3. 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.

4. 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.”

5. 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
NEST
MDIC

6. In 2021 …

7. 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

8. 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

9. Evidence Requirements Are Routinely Established and Updated Through Clinical Collaboratives

10. CDRH is a Gateway to, Not a Gatekeeper of, Valid Scientific Information

11. 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

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

13. Evidence Generation, Evidence Evaluation, and Device Oversight are Global Enterprises

14. 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

15. 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

16. Example

17. 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

18. 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

19. Thank You