Appropriate Regulation of Adjunctive Devices Embolic Protection Sadaf

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

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

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?

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.

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

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!

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!

Helpful Resources • Guidance: Coronary and Carotid Embolic Protection Devices (Issued: February 15, 2008) http: //www. fda. gov/downloads/Medical. Devices/Device. Regulationand Guidance/Guidance. Documents/ucm 071217. pdf • Draft Guidance: The Pre-Submission Program (Issued: July 13, 2012) http: //www. fda. gov/Medical. Devices/Device. Regulationand. Guidance/G uidance. Documents/ucm 310375. htm

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