July Event: Medical Device Regulatory Update


Monthly Program:

Wednesday, 18 July 2018

Device Regulatory Update


Program Speaker:

Janet Trunzo, MS

Sr. Advisor to President and Sr. Executive VP

Technology & Regulatory Affairs


Event Agenda: Date:

Wednesday, July 18th, 2018

Time: 5:15 – 6:00 PM Registration & Snacks

6:00 – 6:05 PM Welcome and Announcements

6:05 – 7:05 PM Program Presentation

7:05 – 7:30 PM Q & A


BD (former CareFusion)

3770 Torrey View Court

San Diego, CA 92130

View Map Program Topic:

Since the passage of the 21st Century Cures Act in December 2016, and the reauthorization of Medical Device User Fee Amendments (MDUFA) and the device-related provision in the FDA Reauthorization Act (FDARA) in August 2017, there are numerous key device regulatory reforms underway at the Agency.

Program Summary:

The talk will provide updates on FDA’s implementation of device regulatory reforms including:

· Breakthrough pathway

· Exemption from 510(k) submissions for low-risk device types

· Application of least burdensome principles

· Process improvements in MDUFA IV

· New MDUFA IV performance goals

· Inspections process improvements

· Streamlined classification for device accessories

The talk will also include an overview of the planned restructuring of CDRH based on a total product life cycle approach.

Speaker Biography:

Janet E. Trunzo is Senior Advisor to the President and Senior Executive Vice President, Technology and Regulatory Affairs, for the Advanced Medical Technology Association (AdvaMed) where she leads a team of regulatory experts. During her tenure at AdvaMed, she has focused on the passage of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), its reauthorization in 2007 and in 2012, and the subsequent negotiation for MDUFA IV. She also concentrates on global regulatory harmonization and represented the U.S. device industry on the Global Harmonization Task Force. Currently, Ms. Trunzo chairs the international Board of Trustees for the Global Medical Device Nomenclature Agency and chairs the Regulatory Committee for the Global Medical Technology Alliance. Prior to joining AdvaMed, Ms. Trunzo held positions at Hybritech, Inc., a medical device and diagnostics manufacturer, and Scripps Clinic and Research Foundation, a hospital, diagnostic clinic and research institute. Ms. Trunzo received her M.S. in health physics from Rutgers University and her B.S. in Chemistry from California University of Pennsylvania.

Please make your reservation early. The online registration due date is Monday, July 16th 2018. Credit Cards are accepted online only. Cash and Check are accepted at the door.

Online Pre-registration (through Monday July 16th, 2018): $15 SDRAN Member, $25 Non-Member

Onsite Registration: $25 SDRAN Member, $35 Non-Member

For Questions Email: programs@sdran.org


From the North 5:

I-5 South toward San Diego

Exit toward Carmel Mountain Rd

Left onto Carmel Mountain Rd

Left onto Torrey View Court

Facility is on the right

From the South 5:

I-5 North toward Del Mar

Merge onto I-5 local Bypass

Take Carmel Mountain Rd exit (32)

Turn right onto Carmel Mountain Rd

Turn left onto Torrey View Court

Facility is on the right