How Is CDRH Structured? 

Elias Mallis 

Director 

Division of Industry and Consumer Education 

Office of Communication Education 

Center for Devices and Radiological Health 

U.S. Food and Drug Administration 
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Learning Objectives

• Describe the organizational structure of FDA’s Center 

for Devices and Radiological Health 

• Identify the individual Offices in CDRH 

• Describe the core functions of CDRH’s “Super Office” 

• Identify the most common points of contact for the 

Center 

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CDRH Basics

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CDRH Background

• Established in 1976 with passage of Medical Device 

Amendments 

• Responsible for regulation of medical devices and 

radiological health products 

– Team - based approach to evaluating product safety and 

effectiveness

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The People at CDRH

• Over 1700 professionals 

• Disciplines: 

– Scientists: Biologists, 

Microbiologists, Chemists, 

Physicists, Toxicologists 

– Engineers 

– Clinicians (Physicians, Nurses) 

– Statisticians, Epidemiologists 

– Veterinarians 

– Lawyers and Policy Professionals 

– Communication, Education, 

Training Specialists 

– Administrative Staff 

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CDRH Organization – At a Glance

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Office of Center 

Director

Office of Policy

Office of Strategic 

Partnership and 

Technology 

Innovation

Office of Product 

Evaluation and 

Quality

Office of 

Communication 

and Education

Office of 

Management

Office of Science 

and Engineering 

Laboratories

CDRH Organization Chart
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Office of Center 

Director

Office of Policy

Office of Strategic 

Partnership and 

Technology 

Innovation

Office of Product 

Evaluation and 

Quality

Office of 

Communication 

and Education

Office of 

Management

Office of Science 

and Engineering 

Laboratories

Office of Center Director (OCD)
Office of Center Director (OCD)

• Provides Center - wide vision, leadership, and 

strategic direction 

• Leads strategic international efforts 

• Leads Center’s Quality Management program 

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Office of Center 

Director

Office of Policy

Office of Strategic 

Partnership and 

Technology 

Innovation

Office of Product 

Evaluation and 

Quality

Office of 

Communication 

and Education

Office of 

Management

Office of Science 

and Engineering 

Laboratories

Office of Policy (OP)
Office of Policy (OP)

• Provides leadership for CDRH policy - related activities 

• Provides Center - clearance for policy including 

guidance documents, regulations, orders 

• Interfaces with FDA Commissioner’s Office and 

relevant Agency Offices 

• Assists in resolution of disputes, grievances and 

appeals (Ombudsman) 

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Office of Center 

Director

Office of Policy

Office of Strategic 

Partnership and 

Technology 

Innovation

Office of Product 

Evaluation and 

Quality

Office of 

Communication 

and Education

Office of 

Management

Office of Science 

and Engineering 

Laboratories

Office of Strategic Partnership and 

Technology Innovation (OST)
Office of Strategic Partnership and 

Technology Innovation (OST)

• Leads scientific collaborative and emerging technology - related 

activities 

• Leads partnerships to advance innovation and regulatory science 

– Notably with healthcare, industry, patient , scientific groups 

• Fosters device innovation

• Leads CDRH effort for public health emergency preparedness and 

response

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Office of Strategic Partnership and 

Technology Innovation (OST)

• Leads Center’s standards and conformity assessment 

program 

• Serves as special projects incubator 

• Strategically leads policy on cybersecurity, software, 

digital health 

• Oversees Center’s data, technology and information 

technology infrastructure

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Office of Product Evaluation and Quality 

(OPEQ)

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Office of Center 

Director

Office of Policy

Office of Strategic 

Partnership and 

Technology 

Innovation

Office of Product 

Evaluation and 

Quality

Office of 

Communication 

and Education

Office of 

Management

Office of Science 

and Engineering 

Laboratories
Office of Product Evaluation and Quality 

(OPEQ)

• Largest Office in CDRH (“Super Office”) 

• Responsible for most day - to - day regulatory 

transactional activities for Center, spanning total 

product life cycle 

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Office of Communication and Education 

(OCE)

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Office of Center 

Director

Office of Policy

Office of Strategic 

Partnership and 

Technology 

Innovation

Office of Product 

Evaluation and 

Quality

Office of 

Communication 

and Education

Office of 

Management

Office of Science 

and Engineering 

Laboratories
Office of Communication and Education 

(OCE)

• Leads strategic regulatory and safety related 

communications to public 

• Leads communications to CDRH Staff 

• Manages FDA portion of website for medical devices 

and radiological health 

• Leads Center Freedom of Information Act and 

Information Disclosure programs

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Office of Communication and Education 

(OCE)

• Manages speaker requests, public meetings and 

workshops 

• Heads video, broadcasting, and webcasting services 

• Manages wide - ranging education to CDRH Staff 

• Leads regulatory education for public: 

– Develops regulatory videos and web content 

– Answer individual questions by phone and email

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Office of Management (OM)

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Office of Center 

Director

Office of Policy

Office of Strategic 

Partnership and 

Technology 

Innovation

Office of Product 

Evaluation and 

Quality

Office of 

Communication 

and Education

Office of 

Management

Office of Science 

and Engineering 

Laboratories
Office of Management (OM)

• Develops and implements Center long - range, strategic, 

and operational plans and budgets 

• Leads Center administrative functions 

• Manages Center financial resources, including contracts 

– Leads CDRH Small Business Program 

• Leads human capital management 

• Administers CDRH Advisory Committee Meetings

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Office of Science and Engineering 

Laboratories (OSEL)

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Office of Center 

Director

Office of Policy

Office of Strategic 

Partnership and 

Technology 

Innovation

Office of Product 

Evaluation and 

Quality

Office of 

Communication 

and Education

Office of 

Management

Office of Science 

and Engineering 

Laboratories
Office of Science and Engineering 

Laboratories (OSEL)

• Leads medical device and radiological health scientific 

research 

– Includes development of methods, evaluation strategies, 

and testing standards 

• Supports development of long - term regulatory 

processes 

• Consults on specialized regulatory issues

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Office of Product Evaluation and Quality

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OPEQ – The Center’s “Super Office”

• Immediate Office (OPEQ - IO) 

• 8 Offices of Health Technology (OHT) 

• Office of Regulatory Programs (ORP) 

• Office of Clinical Evidence and Analysis (OCEA) 

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OPEQ Core Functions

• Implements premarket review programs: 

– notably 510(k), IDE, PMA, HDE, De Novo, Q - submissions 

• Ensures product compliance: 

– registration and listing, recalls, imports and exports, bioresearch monitoring, 

allegations, labeling 

• Evaluates devices in postmarket setting: 

– epidemiology and medical device reporting 

• Fosters development of methodology, analysis, and clinical trial 

infrastructure for evaluation of device safety and effectiveness 

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OPEQ Core Functions

• Administers Federal Law that supports Clinical Laboratory Community 

– Clinical Laboratory Improvement Amendments (CLIA) 

• Regulates radiation - emitting non - medical products 

• Implements Mammography Quality Program 

– Mammography Quality Standards Act (MQSA) of 1992 

• Sets strategy and oversees device - specific clinical evidence and analysis 

and regulatory functions 

– for comprehensive, total product life cycle evaluation

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OPEQ Immediate Office (IO)

• Leads interpretation of regulatory policy and 

guidance 

• Provides support, strategy and oversight to 

OPEQ Offices (OHTs, ORP, OCEA) 

• Lead clinical, scientific, quality, analytic, and 

strategic efforts 

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Office of Health Technology (OHT)

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Office Title Product Area

OHT1 Ophthalmic, Anesthesia, Respiratory, Ear, Nose and Throat (ENT), Dental

OHT2 Cardiovascular

OHT3 Gastro-renal, Obstetrics and Gynecology, General Hospital, Urology

OHT4 Surgical, Infection Control

OHT5 Neurological, Physical Medicine

OHT6 Orthopedic

OHT7 In Vitro Diagnostics

OHT8 Radiological Health

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm
OHT Responsibilities

• Total product life cycle review of product area 

– premarket 

– compliance and quality 

– surveillance 

• Development of policy in product area 

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Office of Regulatory Programs (ORP)

• Manages regulatory programs 

– Provide program support to OHTs 

• Leads establishment support programs 

• Manages market intelligence programs: 

– involving recalls, shortages, allegations, MDR 

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Office of Clinical Evidence and Analysis 

(OCEA)

• Provides policy support for clinical evidence and human protection 

• Provides regulatory oversight of device clinical investigations 

– Including good laboratory/clinical practice (GLP and GCP) 

• Provides biostatistical and epidemiology analyses 

• Outreaches and collaborates with hospitals and external 

stakeholders

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Where Do I Go?

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For General Questions

Division of Industry and Consumer Education (DICE) 

Phone: (800) 638 - 2041 

• Hours of operation: 9 am - 12:30 pm; 1 - 4:30 pm 

Email: dice@fda.hhs.gov

• DICE will respond within 2 business days 

www.fda.gov/DICE

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Device Advice

• Written content 

• Hundreds of pages of total product life cycle 

regulatory information 

• Over 30 regulatory categories 

• “How to” guides 

www.fda.gov/DeviceAdvice

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CDRH Learn

• Multi - media video training modules 

• Presentations, computer - based training, webinars 

• Over 100 modules 

• Most are less than 20 minutes 

• Mobile - friendly 

www.fda.gov/Training/CDRHLearn

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Frequent Points of Contact

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Topic Group Contact Info

Registration and Listing OPEQ/ORP reglist@cdrh.fda.gov

Exports OPEQ/ORP CDRHCECATS@fda.hhs.gov

Unique Device Identification OST www.fda.gov/medical-devices/uniquedevice-identification-system-udisystem/fda-udi-help-desk

Medical Device Reporting OPEQ/ORP MDRPolicy@fda.hhs.gov

Electronic Products – 

Accession Numbers

OHT8 RadHealthCustomerService@fda.hhs.gov

Ombudsman OP CDRHOmbudsman@fda.hhs.gov
References

• Information about CDRH 

www.fda.gov/about-fda/office-medical-products-andtobacco/center-devices-and-radiological-health

• CDRH Management Directory 

www.fda.gov/about-fda/cdrh-offices/cdrh-managementdirectory-organization

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Summary

• FDA’s Center for Devices and Radiological Health is 

organized into 7 offices 

• The Office of Product Evaluation and Quality serves as 

the Center’s “Super Office” 

• OPEQ’s Offices of Health Technology are organized 

into medical disciplines and manages core total 

product life cycle responsibilities 

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Your Call to Action

1. Become familiar with the structure of the Center for 

Devices and Radiological Health 

2. Identify the Office or group with whom you interact 

for your regulatory needs 

3. Use the resources to help you comply with your 

regulatory responsibilities 

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