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Best Practices for Obtaining a Pediatric Indication for Medical Devices

July 7, 2021 @ 3:00 pm - 4:30 pm

$10 – $100

Speakers:

Neil Puri, Director of Quality Assurance

Betsy Garry, Regulatory Affairs Staff Program Manager

Program Manager: Volker Huther, OCRA Treasurer, Managing Member Global Bridge

Synopsis:

U.S. Food and Drug Administration granted Dexcom a De Novo request for the Dexcom G6® CGM System, the newest generation of CGM for people with diabetes ages 2 and up. The purpose of this presentation is to share best practices around expanding an indication to include pediatrics. Coupled with providing a simple and effective ecosystem for parents & caregivers meant improved diabetes management for children and reduced finger sticks. The Dexcom G6 is indicated by the FDA for use as both a standalone CGM and for integration into automated insulin dosing (AID) systems.

Dexcom, Inc. empowers people to take control of diabetes through innovative continuous glucose monitoring (CGM) systems. Headquartered in San Diego, California, Dexcom has emerged as a leader of diabetes care technology. By listening to the needs of users, caregivers, and providers, Dexcom simplifies and improves diabetes management around the world. It has the only CGM device indicated to be used for pediatrics 2+ years of age.

 

*Feel free to email questions ahead of time! [email protected]

 

Speaker Bio:

Neil Puri, Director of Quality Assurance

Neil has a broad range of experience with FDA regulated industries, encompassing quality assurance, design engineering, & project management.  Over 10 years’ experience in the highly developed industries including Class II and III Medical Devices, the nuclear and aerospace industries. Continuity with team leadership, functional management, Quality Leadership integrates the diverse ventures allowing support of business, financial operational and quality goals.   skillset that includes team leadership, functional management, quality assurance, design engineering. Neil makes a point of building a collaborative, driven and fun work environment.

 

Betsy Garry, Regulatory Affairs Staff Program Manager 

Betsy is a fourteen-year veteran medical device company contributor to Regulatory Affairs and Clinical Affairs. She Initiated and continues to lead Cross Functional Claims Review Meetings to document and control new and ongoing product claims for HCP, DTC, Instruction/Education, Social and Digital Media. With an RA/CA team, they completed two PMDA Good Clinical Practices regulatory audit meetings concerning data from three clinical trials resulting in Dexcom’s first approved product in Japan. All in a days she has been involved in submitting 510(k), 30-Day Notice, IDE Closure, and Annual Reports to FDA

Betsy says she credits her tenure to being an organizational/social leader, detail oriented with a positive attitude, and serving collaboratively on core teams to achieve corporate goals at a fast pace.

Details

Date:
July 7, 2021
Time:
3:00 pm - 4:30 pm
Cost:
$10 – $100
https://ocra-dg.org/event/robots-are-here-digital-health-ai-and-you/

Venue

Instrument Kit03