1. Appropriate Regulation of Adjunctive Devices: Embolic Protection
Sadaf A. Toor, M.S.
LT, U.S. Public Health Service Biomedical Engineer  Peripheral Interventional Devices Branch Office of Device Evaluation Food and Drug Administration
February 25, 2013

2. I/we have no real or apparent conflicts of interest to report.
Sadaf A. Toor, M.S.
I/we have no real or apparent conflicts of interest to report.

3. FAQs Regulatory Pathway? 510(k) or PMA? 510(k) with clinical data
Will my submission go to Panel? Maybe. These are first of a kind devices, and 510(k)s can go to Panel.
New questions of S&E?
Quality/strength of data collected?

4. FAQs (cont.)
Is a RCT needed? No, but there should be an appropriate control and data should be recent.
Can I use OUS Data? Yes, some but not all. OUS patient population and medical practice should compare to US.
What endpoints should we study? Include an assessment of both safety and effectiveness. 4

5. Safety and Effectiveness
emboli caused by the device?
risk for perforation, dissection
Effectiveness: preventing stroke
Imaging: DW-MRI
Neurocognitive measurements for clinical sequelae
Use an appropriate control 5

6. Pre-clinical Testing Risk-based analysis
Coronary and Carotid EPD Guidance (2008)
can be a good starting point
geared towards filter and balloon type devices
Not all testing may apply AND may not cover all testing necessary
RISK ANALYSIS! 6

7. Seek FDA Feedback early
Make use of the Pre-Submission Program as a
tool for obtaining feedback
It’s never too early to talk to us! 7

8. Helpful Resources
Guidance: Coronary and Carotid Embolic Protection Devices (Issued: February 15, 2008)
Draft Guidance: The Pre-Submission Program (Issued: July 13, 2012) 8

9. E-mail: Sadaf.Toor@fda.hhs.gov
Questions?
                     
Thank you! 9