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Center for Devices and Radiological Health

View detailed information about Center for Devices and Radiological Health, including compliance records, people, and regulatory data.

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Office Profile

Comprehensive profile of Center for Devices and Radiological Health, including its role, location, and regulatory activities.

People (9)
Jason Brookbank
FDA_ASSOCIATED_PERSON
Robert J. Deininger
FDA_ASSOCIATED_PERSON
Richard L. Friedman
FDA_ASSOCIATED_PERSON
John R. Marzilli
FDA_ASSOCIATED_PERSON
Ronald C. Nelson
FDA_ASSOCIATED_PERSON
Leana Barreto-Pettit
FDA_ASSOCIATED_PERSON
Kristina Donohue
FDA_ASSOCIATED_PERSON
Wilvor K. Butler
FDA_ASSOCIATED_PERSON
Robert G. Ruff
INVESTIGATOR
Records (20)
WARNING_LETTER - Health, Wealth, & Happiness

Devices • February 17, 2010

WARNING_LETTER
WARNING_LETTER - IPCH Management, Inc

Devices • February 3, 2010

WARNING_LETTER
WARNING_LETTER - Opternative Inc

Devices • October 30, 2017

WARNING_LETTER
WARNING_LETTER - Caliber Imaging & Diagnostics, Inc.

Devices • January 8, 2015

WARNING_LETTER
WARNING_LETTER - Dornier Medtech America, Inc.

Devices • March 23, 2010

WARNING_LETTER
WARNING_LETTER - Palmdale Ambulatory Surgery Center

Devices • December 9, 2011

WARNING_LETTER
WARNING_LETTER - Medica Outlet

Devices • June 1, 2015

WARNING_LETTER
WARNING_LETTER - Baxter Healthcare Corporation

Devices • April 1, 2013

WARNING_LETTER
WARNING_LETTER - Pressure Tech Inc

Devices • August 8, 2013

WARNING_LETTER
WARNING_LETTER - The Reynolds Office of Health and Nutrition

Devices • August 8, 2013

WARNING_LETTER
WARNING_LETTER - 23andMe Genomics LLC

Devices • November 22, 2013

WARNING_LETTER
WARNING_LETTER - Alveologic LLC

Devices • April 11, 2013

WARNING_LETTER
WARNING_LETTER - Meditherm Inc.

Devices • April 4, 2011

WARNING_LETTER
WARNING_LETTER - AngioDynamics, Inc.

Devices • January 21, 2011

WARNING_LETTER
WARNING_LETTER - Veinwave Ltd

Devices • May 12, 2014

WARNING_LETTER
WARNING_LETTER - CNS Response Inc

Devices • April 10, 2008

WARNING_LETTER
WARNING_LETTER - Body, Mind & Soul, Inc.

Devices • March 13, 2013

WARNING_LETTER
WARNING_LETTER - Mectra Labs, Inc.

Devices • November 14, 2013

WARNING_LETTER
WARNING_LETTER - Aesthetics Systems Usa Inc

Devices • May 22, 2014

WARNING_LETTER
WARNING_LETTER - Pacific Vision Institute

Devices • August 14, 2014

WARNING_LETTER

Showing 1 to 20 of 20 records

Guidance Documents (10)
Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency: Guidance for Industry and Food and Drug Administration Staff
Guidance
Electronic Submission Template for Investigational Device Exemption (IDE) Applications: Draft Guidance for Sponsors and Food and Drug Administration Staff
Guidance
Robotically-Assisted Surgical Devices - Premarket Submissions: Draft Guidance for Industry and Food and Drug Administration Staff
Guidance
Electronic Submission Template for Premarket Approval Applications (PMA): Draft Guidance for Industry and Food and Drug Administration Staff
Guidance
Dental Composite Resin Devices - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff 
Guidance
Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements: Guidance for Industry and Food and Drug Administration Staff
Guidance
Content of Human Factors Information in Medical Device Marketing Submissions: Guidance for Industry and Food and Drug Administration Staff
Guidance
Patient-Matched Guides for Orthopedic Implants: Guidance for Industry and Food and Drug Administration Staff
Guidance
Compliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Air-Purifying Respirators: Draft Guidance for Industry and Food and Drug Administration Staff
Guidance
Medical Devices with Indications Associated with Weight Loss - Premarket Considerations: Guidance for Industry and Food and Drug Administration Staff
Guidance
Related Offices (5)
Office of Compliance Intervention and Consultation
OCIC
Acting Division Director
Bureau of Environmental Health
Division of Nonprescription Drug Products
Division of Reproductive and Urologic Products
Office Information

Name

Center for Devices and Radiological Health

Abbreviation

CDRH

Country

USA

Postal Code

20993

State/Province

Maryland

City

Silver Spring

Address

10903 New Hampshire Avenue

Office Website

Visit Website

ID: 9d89aff6-e435-4764-87be-f58c01aca7f7

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🇪🇺+48 532-447-507
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