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

Changes Made to Approval Mechanism for COVID-19 Test Kits

FDA Issues Guidance on Laboratory Developed Tests (PDT) for Highly Pathogenic Avian Influenza (HPAI)

Industry Advisory: New Labeling Law Affecting the Manufacture, Sale, and Distribution of Menstrual Products Effective January 1, 2023 (PDF)

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 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 and Pilot Covid-19 At 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

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

Decorative Contact Lenses - Corneal Ulcers

Publications and Reports

2024 Drug and Device Fund Report (PDF)

2023 Drug and Device Fund Report (PDF)

2022 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

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, 2024) (PDF)

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

HMDR California Facility License Application: CDPH 8679 (PDF)

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

HMDR Exemptee Application: CDPH 8695 (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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