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Regulatory Affairs Support

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.

Regulatory Affairs Content

Regulatory Affairs Newsletters

Publications, White Papers & Presentations

 

Relevant 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.
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