Food and drug branch (FDB)

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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

Health Advisory: Cybersecurity FAQs (PDF)

Health Advisory: Decorative Contact Lenses (PDF)

FDA Recall: Jiangsu Well Biotech Co., Ltd. Recalls COVID-19 Ag Rapid Test Devices (PDF)

Extended Expiration Date: MaximBio COVID-19 Antigen Home Test

FDA Alert: Counterfeit At-Home OTC COVID-19 Diagnostic Tests

FDA Safety Communication: FDA Warns Against Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures

FDA Cybersecurity Notice: Vulnerabilities identified in medical device software components: PTC Axeda agent and Axeda Desktop Server

FDA Safety Communication: Do Not Use SD Biosensor STANDARD Q COVID-19 Ag Home Tests

FDA Safety Communication: Potential Risk of Strangulation in Children who Use Enteral Feeding Delivery Sets

FDA Safety Communication: Stop Using LuSys Laboratories COVID-19 Tests

Health Advisory: Defective Imported Medical Gloves (PDF)

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

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)

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

Publications and Reports

2022 Drug and Device Fund Report (PDF)

2021 Drug and Device Fund Report (PDF)

2020 Drug and Device Fund Report (PDF)

2019 Drug and Device Fund Report (PDF)

2018 Drug and Device Fund Report (PDF)

2017 Drug and Device Fund Report (PDF)

2016 Drug and Device Fund Report (PDF)

2013-2015 Drug and Device Fund Report (PDF)

Regulations and Statutes

Emergency Use Authorization

Title 21 Code of Federal Regulations - Good Manufacturing Practices

Guidelines

FDA Guidance to Industry

FDA Guidance Policy on COVID-19-Related Sanitation Tunnels (PDF)

Procedure for Obtaining a New Medical Device License (PDF)

Medical Device Safety Program FAQs (PDF)

Medical Device Safety Program Licensing Requirements (PDF)

Certificates and Licenses

Medical Device License Fees (Effective July 1, 2022) (PDF)

Medical Device Manufacturing Application: New Applicant, Ownership Change, Rewnewal, and Relocation: CDPH 8596 Updated Fees (PDF)

HMDR California Facility License Application: CDPH 8679 Updated Fees (PDF)

HMDR Out-of-State Facility License Application: CDPH 8679O Updated Fees (PDF)

HMDR Exemptee Application: CDPH 8695 Updated Fees (PDF)

FDB License / Registration Verification Request Form: CDPH 8707 (PDF)

Resources

Device Discontinuance List

FDA: Face Masks, Including Surgical Masks, and Respirators for COVID-19

The U.S. FDA Announces EUA For First COVID-19 Diagnostic Test Where Results Can Be Read Directly From Testing Card - Abbott Diagnostics Scarborough, Inc.’s BinaxNOW COVID-19 Ag Card

FDA COVID-19 Updates

FDA Import Alert - Contact Lenses

FDA MedWatch Reporting Link

FDA Medical Device Safety

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