Who We Are

The Program Operations and Management within the Office of Health Technology 7 within CDRH's Office of Product Evaluation and Quality (OPEQ) responsible for review of chemistry and toxicology in vitro diagnostic devices, such as in vitro diagnostics for clinical chemical devices, diabetes, toxicology and cardio-renal.

What We Do

Division of Chemistry and Toxicology Devices

• Serve as the primary source for scientific and medical expertise with regard to safety and effectiveness of medical devices throughout the total product lifecycle.
• Provide initial support for questions related to regulatory programs in response to requests from medical device and health technology industries, trade associations, other Federal agencies, other countries, State agencies, and the general public.
• Advise, coordinate, and provide consultation to the OPEQ Director and other Agency officials on Office programs and policies concerning premarket review, compliance and quality, and postmarket surveillance activities.
• Coordinate, carry out, and make premarket review determinations (e.g., 510(k), PMA, HDE, DeNovo, IDE, etc.).
• Coordinate, carry out and make postmarket compliance and quality determinations (e.g., Establishment Inspection Report, Regulatory Audit Reports, Recalls, Allegations of Regulatory Misconduct, Labeling, Enforcement Actions, etc.).
• Coordinate, carry out, and make postmarket surveillance determinations (e.g., Medical Device Reports, Post Market Surveillance Studies, Safety Signals, etc.). 
• Participate in development and interpretation of regulations and policies.
• Coordinate actions on classification.
• Review and evaluate design, test, and production data and reports from manufacturers to ensure compliance with promulgated standards and regulations.
• Participate in the development of national and international consensus standards, and voluntary guidelines through interaction with national and international standards committees.
• Categorize tests based on complexity, reviews and decides on requests for Waiver by Application, and develops rules/guidance for Clinical Laboratory Improvement Amendments (CLIA) complexity categorization.

Who We Are

The Division of Immunology and Hematology within the Office of Health Technology 7 within CDRH's Office of Product Evaluation and Quality (OPEQ) responsible for review of immunology and hematology in vitro diagnostics devices.

What We Do

Division of Immunology and Hematology

• Serve as the primary source for scientific and medical expertise with regard to safety and effectiveness of medical devices throughout the total product lifecycle.
• Provide initial support for questions related to regulatory programs in response to requests from medical device and health technology industries, trade associations, other Federal agencies, other countries, State agencies, and the general public.
• Advise, coordinate, and provide consultation to the OPEQ Director and other Agency officials on Office programs and policies concerning premarket review, compliance and quality, and postmarket surveillance activities.
• Coordinate, carry out, and make premarket review determinations (e.g., 510(k), PMA, HDE, DeNovo, IDE, etc.).
• Coordinate, carry out and make postmarket compliance and quality determinations (e.g., Establishment Inspection Report, Regulatory Audit Reports, Recalls, Allegations of Regulatory Misconduct, Labeling, Enforcement Actions, etc.).
• Coordinate, carry out, and make postmarket surveillance determinations (e.g., Medical Device Reports, Post Market Surveillance Studies, Safety Signals, etc.). 
• Participate in development and interpretation of regulations and policies.
• Coordinate actions on classification.
• Review and evaluate design, test, and production data and reports from manufacturers to ensure compliance with promulgated standards and regulations.
• Participate in the development of national and international consensus standards, and voluntary guidelines through interaction with national and international standards committees.
• Categorize tests based on complexity, reviews and decides on requests for Waiver by Application, and develops rules/guidance for Clinical Laboratory Improvement Amendments (CLIA) complexity categorization.

Who We Are

The Division of Mammography Quality Standards within the Office of Health Technology 7: Office of In Vitro Diagnostics and Radiological Health within CDRH's Office of Product Evaluation and Quality (OPEQ) is responsible for ensuring all women have access to quality mammography through implementation of the Mammography Quality Standards Act (MQSA).

What We Do

• Develop, implement, and oversee requirements and policies related to mammography facility accreditation, certification, and inspection, reporting, recordkeeping, and user-fees.
• Provide oversight of and enforce compliance actions on mammography facilities which may not adhere to the imaging, personnel, and reporting standards required by the MQSA.
• Work with state regulatory agencies and the Office of Regulatory Affairs to conduct annual inspections of over 8700 certified facilities.
• Issue public notices when a facility is not in compliance with MQSA standards and has provided mammography imaging services that are not at a level that is established to be safe and effective.
• Collaborate and provide oversight with key partners such as accreditation bodies and state certifying agencies which are responsible for implementation of parts of the MQSA.
• Develop training material and coursework and train new mammography facility inspectors from state and FDA district offices.
• Maintain inspection software and facility database applications to capture inspection and key facility data such as accreditation and certification information.

Who We Are

The Division of Microbiology Devices within the Office of Health Technology 7 within CDRH's Office of Product Evaluation and Quality (OPEQ) responsible for review of viral respiratory, HPV, general viral, hepatitis, general bacteria, antimicrobial susceptibility, bacterial respiratory and medical countermeasures in vitro diagnostics devices.

What We Do

Division of Microbiology Devices

• Serve as the primary source for scientific and medical expertise with regard to safety and effectiveness of medical devices throughout the total product lifecycle.
• Provide initial support for questions related to regulatory programs in response to requests from medical device and health technology industries, trade associations, other Federal agencies, other countries, State agencies, and the general public.
• Advise, coordinate, and provide consultation to the OPEQ Director and other Agency officials on Office programs and policies concerning premarket review, compliance and quality, and postmarket surveillance activities.
• Coordinate, carry out, and make premarket review determinations (e.g., 510(k), PMA, HDE, DeNovo, IDE, etc.).
• Coordinate, carry out and make postmarket compliance and quality determinations (e.g., Establishment Inspection Report, Regulatory Audit Reports, Recalls, Allegations of Regulatory Misconduct, Labeling, Enforcement Actions, etc.).
• Coordinate, carry out, and make postmarket surveillance determinations (e.g., Medical Device Reports, Post Market Surveillance Studies, Safety Signals, etc.). 
• Participate in development and interpretation of regulations and policies.
• Coordinate actions on classification.
• Review and evaluate design, test, and production data and reports from manufacturers to ensure compliance with promulgated standards and regulations.
• Participate in the development of national and international consensus standards, and voluntary guidelines through interaction with national and international standards committees.
• Categorize tests based on complexity, reviews and decides on requests for Waiver by Application, and develops rules/guidance for Clinical Laboratory Improvement Amendments (CLIA) complexity categorization.

Who We Are

The Division of Molecular Genetics and Pathology within the Office of Health Technology 7 within CDRH's Office of Product Evaluation and Quality (OPEQ) responsible for review of molecular genetics and pathology in vitro diagnostics, such as

What We Do

Division of Molecular Genetics and Pathology

• Serve as the primary source for scientific and medical expertise with regard to safety and effectiveness of medical devices throughout the total product lifecycle.
• Provide initial support for questions related to regulatory programs in response to requests from medical device and health technology industries, trade associations, other Federal agencies, other countries, State agencies, and the general public.
• Advise, coordinate, and provide consultation to the OPEQ Director and other Agency officials on Office programs and policies concerning premarket review, compliance and quality, and postmarket surveillance activities.
• Coordinate, carry out, and make premarket review determinations (e.g., 510(k), PMA, HDE, DeNovo, IDE, etc.).
• Coordinate, carry out and make postmarket compliance and quality determinations (e.g., Establishment Inspection Report, Regulatory Audit Reports, Recalls, Allegations of Regulatory Misconduct, Labeling, Enforcement Actions, etc.).
• Coordinate, carry out, and make postmarket surveillance determinations (e.g., Medical Device Reports, Post Market Surveillance Studies, Safety Signals, etc.). 
• Participate in development and interpretation of regulations and policies.
• Coordinate actions on classification.
• Review and evaluate design, test, and production data and reports from manufacturers to ensure compliance with promulgated standards and regulations.
• Participate in the development of national and international consensus standards, and voluntary guidelines through interaction with national and international standards committees.
• Categorize tests based on complexity, reviews and decides on requests for Waiver by Application, and develops rules/guidance for Clinical Laboratory Improvement Amendments (CLIA) complexity categorization.

Who We Are

The Program Operations and Management within the Office of Health Technology 7: Office of In Vitro Diagnostics and Radiological Health within CDRH's Office of Product Evaluation and Quality (OPEQ) is responsible for the OPEQ Third Party Submission Program, office specific programs, such as the Clinical Laboratory Improvement Amendments (CLIA) program, and office operations.

What We Do

• Develop and implement policy and processes to ensure quality and consistency across the regulatory submission programs
• Provide programmatic expertise for the Third-Party Submission program to industry and all OPEQ staff
• Determine policy for and oversee the Clinical Laboratory Improvement Amendments (CLIA) program
• Provide support to industry when interfacing with the various regulatory submission programs managed in DPOM

Who We Are

The Division of Radiological Health within the Office of Health Technology 7 within CDRH's Office of Product Evaluation and Quality (OPEQ) responsible for review of magnetic resonance, electronic products, diagnostic X-ray systems, nuclear medicine, radiation therapy, mammography, ultrasound and imaging software.

What We Do

Division of Radiological Health

• Serve as the primary source for scientific and medical expertise with regard to safety and effectiveness of medical devices throughout the total product lifecycle.
• Provide initial support for questions related to regulatory programs in response to requests from medical device and health technology industries, trade associations, other Federal agencies, other countries, State agencies, and the general public.
• Advise, coordinate, and provide consultation to the OPEQ Director and other Agency officials on Office programs and policies concerning premarket review, compliance and quality, and postmarket surveillance activities.
• Coordinate, carry out, and make premarket review determinations (e.g., 510(k), PMA, HDE, DeNovo, IDE, etc.).
• Coordinate, carry out and make postmarket compliance and quality determinations (e.g., Establishment Inspection Report, Regulatory Audit Reports, Recalls, Allegations of Regulatory Misconduct, Labeling, Enforcement Actions, etc.).
• Coordinate, carry out, and make postmarket surveillance determinations (e.g., Medical Device Reports, Post Market Surveillance Studies, Safety Signals, etc.). 
• Participate in development and interpretation of regulations and policies.
• Coordinate actions on classification.
• Review and evaluate design, test, and production data and reports from manufacturers to ensure compliance with promulgated standards and regulations.
• Participate in the development of national and international consensus standards, and voluntary guidelines through interaction with national and international standards committees.
• Develop, oversee and implement requirements and policies related to reports of problems and hazards, product reports, supplemental reports, abbreviated reports, and annual reports, exemptions from reporting, requests for variances, and recordkeeping.