SERVICES | regulatory affairs program

Quick Links

Relevant External Links*

• Centers for Medicare and Medicaid Services

• Department of Health and Human Services

• Food and Drug Administration

• Food and Drug Law Institute

• Massachusetts Medical Device Industry Council

• National Institutes of Health

• Info for FDA-Regulated Industry

• Medical Device Regulations - FDA

* CIMIT and all affiliated entities do not endorse the information from external links, nor are they responsible for the availability, accuracy, or content of these sites.

Contact: Colleen Kigin, DPT
Advisor: John J. Smith, MD, JD

CIMIT’s Regulatory Affairs program provides a unique national resource to identify, characterize, and recommend strategies to address key regulatory and coverage/payment challenges throughout the product development lifecycle.

In support of its research and science programs, CIMIT monitors emerging regulatory issues of interest to the medical technology community, including:

Monitoring systemic regulatory and coverage/payment issues impacting the clinical introduction of innovative medical technology.
Assisting CIMIT members and collaborators with project-specific regulatory and coverage/payment issues.
Providing information on current issues and trends for the CIMIT community through periodic Regulatory Affairs Newsletters.