Dawnbreaker MRR
  • Vaccines, Blood & Biologics
    • Allergenics
    • Blood and Blood Products
    • Cellular and Gene Therapy
    • Tissue and Tissue Products
    • Xenotransplantation
    • Vaccines
  • Biotechnology
  • Drugs
    • Drug Development Process
    • Biosimilars
    • Investigational New Drug Application
    • New Drug Application
    • Orphan Drugs
    • Small Business Assistance
  • Food and Drug Administration
    • Center for Biologics Evaluation and Research
    • Center For Device and Radiological Health
    • Center for Drug Evaluation and Research
    • Center for Food Safety and Applied Nutrition
    • Center for Veterinary Medicine
    • Office of Regulatory Affairs
  • Medical Devices
    • Definition
    • Premarket Notification (510(k))
    • Premarket Approval
    • Guidance and Standards
    • Software Validation
    • Quality Systems
    • Small Business Support
  • Veterinary Products
    • Animal Drug Approval Process
    • Animal Food & Feeds
    • Veterinary Devices
    • Animal Biotechnology
Dawnbreaker MRR
  • Vaccines, Blood & Biologics
    • Allergenics
    • Blood and Blood Products
    • Cellular and Gene Therapy
    • Tissue and Tissue Products
    • Xenotransplantation
    • Vaccines
  • Biotechnology
  • Drugs
    • Drug Development Process
    • Biosimilars
    • Investigational New Drug Application
    • New Drug Application
    • Orphan Drugs
    • Small Business Assistance
  • Food and Drug Administration
    • Center for Biologics Evaluation and Research
    • Center For Device and Radiological Health
    • Center for Drug Evaluation and Research
    • Center for Food Safety and Applied Nutrition
    • Center for Veterinary Medicine
    • Office of Regulatory Affairs
  • Medical Devices
    • Definition
    • Premarket Notification (510(k))
    • Premarket Approval
    • Guidance and Standards
    • Software Validation
    • Quality Systems
    • Small Business Support
  • Veterinary Products
    • Animal Drug Approval Process
    • Animal Food & Feeds
    • Veterinary Devices
    • Animal Biotechnology

Center for Devices and Radiological Health (CDRH) 

In 2019, the FDA's Center for Devices and Radiological Health's (CDRH) reorganized, creating an agile infrastructure that can adapt to future organizational, regulatory and scientific needs. The reorganization did not change the mission of CDRH. FDA sources indicate that the CDRH reorganization is designed to improve organizational efficiencies to better meet public health needs, noting that CDRH's premarket and postmarket program functions will be integrated along product lines. The current CDRH structure, following reorganization, follows:

Org image source

The following bullets capture the CDRH management directory, by organization:

  • Office of the Center Director
  • Office of Communication and Education
  • Office of Management
  • Office of Policy
  • Office of Product Evaluation and Quality
  • Office of Science and Engineering Laboratories
  • Office of Strategic Partnerships and Technology Innovation

The CDRH offers assistance and information to small businesses and other medical device manufacturers here. This includes online courses on the safety and effectiveness of medical devices and exposure to radiation from medical devices; a list of upcoming workshops and conferences dealing with FDA approval of medical devices; as well as facilitating the Medical Device Fellowship Program, where health professionals can participate in the FDA regulatory process for medical devices. Additional resources available through the CDRH for industry include the Device Advice page on product and regulatory information, bringing a device to market, a searchable medical device database, and COVID 19 resources.[3]

Updated by Theresa Pipher, November 2020

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