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Food and drug branch (FDB)

 FDB Home Page

 Contact

Main Telephone:

(800) 495-3232

 

Email:

FDBMedDevice@cdph.ca.gov

 

Address (Courier Delivery):

California Department of Public Health - Food and Drug Branch

1500 Capitol Ave, MS 7602

Sacramento, CA 95814

 

Address (Non-Courier Delivery):

California Department of Public Health - Food and Drug Branch

P.O. Box 997435, MS 7602

Sacramento, CA 95899

Medical Device Safety Program

The Medical Device Safety Section's mission is to provide an uncompromising standard of public health protection by assuring that medical devices produced and retailed 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 with industry and public sector through our commitment to fair business and regulatory practices.

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

For any questions, please contact us using the information on the left or email us as the following address: FDBMedDevice@cdph.ca.gov.

 News and Updates

FDA Recall: GORE Cardioform Septal Occluders (PDF)

FDA Recall: Smiths Medical Endotracheal Tubes (PDF)

FDA Recall: Karl Storz Endoscopy (PDF)

FDA Recall: 3M Redot Electrode (PDF)

FDA Recall: Siemens Healthcare EUA for SARS-CoV-2 Antigen Assays (PDF)

FDA Recall: GE Healthcare Recalls MRI Software (PDF)

FDA Recall: Medtronic sterile single-use blades (PDF)

FDA Recall: Stradis Healthcare (PDF)

FDA Recall: BD-Bard Misbrands Biopsy Needle (PDF)

FDA Recall: Zimmer Biomet-ROSA One 3.1 Brain Application (PDF)

FDA Recall: Datascope/Getinge/Maquet Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump Battery Packs (PDF)

FDA Recall: Siemens Healthcare Diagnostics, Inc.-Ancillary Reagant Packs (PDF)

FDA Recall: DiaSorin Molecular LLC-Simplexa COVID-19 Positive Control Pack (PDF)

FDA Recall: LimaCorporate Self-tapping Titanium Alloy Bone Screw (PDF)

Health Advisory-Decorative Contact Lenses (PDF)

CDPH News Release-​CDPH Warns Consumers about Risks of Wearing Decorative Contact Lenses

FDA Recall: Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP Kit (PDF)

Phillips Respironics CPAP, BiPAP, and Ventilator Recall (PDF)

FDA Recall: Cordis Super Torque MB Angiographic Catheter with Radiopaque Marker Bands (PDF)

FDA Recall: Imperative Care Inc., -Zoom 71 Reperfusion Catheter (PDF)

FDA Alert: Stop using Certain N95 Respirators Manufactured by Shanghai Dasheng - Letter to Health Care Providers

FDA Alert :  Stop Using Innova SARS-CoV-2 Antigen Rapid Qualitative Test - FDA Safety Communication

FDA MedWatch-JET 7 Catheters with Xtra Flex Technology by Penumbra: Recall-Due to Increased Risk of Mortality and Serious Injury

FDA Alert: An Increased Risk of a False Positive Result with BD SARS-CoV-2 Reagentsfor the BD Max System Test

Governor Newsom Signs Executive Order on Actions in Response to COVID-19 6.5.20

Executive Order N-68-20 (PDF)

Medical Device License Fees (Effective September 1, 2020) (PDF)

Statement from FDA Commissioner Scott Gottlieb, M.D., on signing of the Agriculture Improvement Act and the agency’s regulation of products containing cannabis and cannabis-derived compounds

Decorative Contact Lenses - Corneal Ulcers

Decorative Contact Lenses - Corneal Edema

Decorative Contact Lenses - Eye Redness

Decorative (Colored) Contact Lenses - Corneal Ulcer

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