Medical Device User Fee Reauthorization & FDA Update

1. Medical Device User Fee Reauthorization & FDA Update Roadmap to a Successful 510(K) Submission For Your Medical Device August 22, 2012

2. AGENDA • How Did We Got Here? • Device User Fee Renewal • FDA Regulatory Environment

3. 510(k) review times have risen 46% since 2007 as approval volume has trended down

4. User Fee Reauthorization: 510(k) Performance Improvements • Decision made within 90 (FDA) Days • 2013: 91% of submissions • 2014: 94% • 2015: 95% • Avg total time to decision in calendar days • 2013 submissions: 135 days • 2015 submissions: 130 days • 2017 submissions: 124 days

5. User Fee Reauthorization: Regulatory Process Reforms • Communications/Interaction Improvements • Pre-Submission meetings • Midway review feedback (60 day from submission for 510(k)s) • Documentation/Review of Agency decisions • Submitter may request supervisory review within 30 days of decision

6. User Fee Reauthorization: Regulatory Process Reforms • IDE Standard – Agency cannot disapprove IDEs because the investigation does not: • support a substantial equivalence or de novo determination or approval • may not meet any requirement (including data requirement) • additional or different investigations may be necessary to support clearance or approval of the device.

7. User Fee Reauthorization: Regulatory Process Reforms • 510(k) Modifications: • Agency forced to withdraw draft guidance • Require Agency to submit report to Congress addressing the key substantive, and controversial, provisions of the guidance • Precludes Agency from issuing regulation or guidance before 1 year after submission of the report

8. User Fee Reauthorization: Regulatory Process Reforms • De Novo Process Modification: • Eliminates NSE requirement • Allows de novo submitters to submit request for classification and draft special controls • Establishes 120 day timeline for FDA to classify the device • FDA can refuse de novo request where: • A predicate exists • Device is not low or moderate risk • General controls or special controls cannot mitigate risks

9. User Fee Reauthorization: Regulatory Process Reforms • Clarification of Least Burdensome standard • Reauthorization of Third-Party Review • Device Reclassification Procedures • Humanitarian Device Exemptions • Unique Device Identifier (UDI) -- for devices that are implantable, life-saving and life-sustaining • Inclusion of devices in FDA Sentinel program

10. FDA Regulatory Environment:Medical Device Tax • Begins in 2013 • $30 billion tax • Potential 43,000 jobs lost • Update on repeal efforts

11. Healthcare Reform Implementation • Supreme Court ruling offers some finality • Next major steps: • Accountable Care Organizations • Essential benefits package • Insurance exchanges • Medicaid expansion • Independent payment advisory board • Impact on VC & start-ups