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Food and Drug Branch

Medical Device Safety Program

Device Regulation in California

Device Questions and Answers

New Device Manufacturing License Application (pdf)

Biennial Medical Device Manufacturing License Renewal Application

Home Medical Device Retailer Licensing System

Medical Device Section and Unit Contacts

Update - Drug and Device License Fees

Report to the Legislature - Drug Manufacturing, Medical Device Manufacturing, and Home Medical Device Retailer Licensing Costs and Fee Analysis

MEDICAL DEVICE SAFETY SECTION CONTACT:  Ingeborg Small,  Section Chief,  (916) 650 6500

The Medical Device Safety Program's mission is to provide an uncompromising standard of public health protection by assuring that medical devices produced in California are safe and effective. We accomplish our mission through scientific-based investigations and specific legal authority, uniformity of enforcement, balanced with effective industry and consumer education by employing leading-edge technology. We also endeavor to achieve a partnership of trust with the industry and public sector through our commitment to fair business and regulatory practices.

Our vision is to be a globally recognized model for medical device safety program excellence that fosters industry growth and technological innovation, creates a fair and scientific-based regulatory environment that attracts responsible industry to California, and assures public health protection for all users of California-produced devices.


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