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Device and Diagnostic Innovation

Medical Devices, In Vitro Diagnostics, and Combination Products

Day & Time:
June 17, 10:30AM - 12:00PM (Pacific Standard Time)

Session Number:

Room Number:



Device and Diagnostic Innovation

Janet Jenkins-Showalter
Senior Regulatory Group Director, Regulatory Policy and Intelligence
Genentech, A Member of the Roche Group, United States

US patients and physicians must sometimes wait years for promising new technologies to reach the market. In an effort to shorten development time, the Center for Devices and Radiological Health (CDRH) has initiated a number of innovative programs to ensure that the necessary regulatory pathways are established to maintain pace with scientific advances, such as the Innovation Pathway (similar to CDER’s breakthrough therapy designation), the Medical Device Innovation Consortium (MDIC), Entrepreneurs-in-Residence, and the Pediatric Device Consortia. Additionally, CDRH is considering the possibility of shifting some of the premarket effectiveness data requirements to the postmarketing setting as a potential way to accelerate patient access to innovative devices.

In this session, we will discuss a program instituted by PEW Charitable Trusts to use registry data to support device preapproval and clearance. This program uses a variety of approaches to utilize the information contained in registries; for example, in cardiovascular devices the data has recently been used as a control group to support PMA approval and reimbursement. Additionally, the possibility of using a risk-based approach for approval of in vitro companion diagnostics associated with therapies that have breakthrough designation will be discussed. New technologies that are on the horizon and could stretch the limits of CDRH’s current approval pathways also will be considered. We will also review the activities of the MDIC, which includes CDRH participants, and is focusing on accelerating the development, assessment and review of new medical devices.

Learning Objective(s):
Describe CDRH’s current initiatives related to innovative approaches for the review and approval of promising new technologies; Explain the blueprint for accelerating in vitro diagnostics and companion diagnostics for breakthrough drugs; Identify new technologies and possible changes to CDRH’s current regulatory approval pathways.

Presentation(s) & Speaker(s):
Regulating Diagnostics for Breakthrough Therapies
Mya Thomae, RAC
Founder and Chief Executive Officer
Myraqa, United States

Kirsten H. Paulson, MS, RAC
Senior Director, Global CMC-Medical Devices
Pfizer Inc, United States

Michelle McMurry-Heath, MD, PhD
Senior Director, Regulatory Strategy
FaegreBD Consulting , United States