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  6. OHT7: Office of In Vitro Diagnostics, Office of Product Evaluation and Quality
  1. CDRH Offices

OHT7: Office of In Vitro Diagnostics, Office of Product Evaluation and Quality

Who We Are

The Office of Health Technology 7: Office of In Vitro Diagnostics within CDRH's Office of Product Evaluation and Quality (OPEQ) is responsible for the total product lifecycle (TPLC) activities for in vitro diagnostics.

What We Do

For in vitro diagnostics medical devices, we: 

  • Implement a TPLC model for the office's medical device product area.  The TPLC model includes implementation of premarket review programs (e.g., 510(k), PMA, HDE, DeNovo, IDE), compliance and quality programs (e.g., Establishment Inspection Report, Regulatory Audit Reports, Recalls, Allegations of Regulatory Misconduct, Labeling, Enforcement Actions), and surveillance programs (e.g., Medical Device Reports, Post Market Surveillance Studies, Safety Signals). 
  • 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.
  • 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, make determinations on requests for Waiver by Application, and develops rules and guidance for Clinical Laboratory Improvement Amendments (CLIA) complexity categorization.

Office Organization

Who We Are

The Division of Chemistry and Toxicology Devices is 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

For chemistry and toxicology in vitro diagnostic devices, such as in vitro diagnostics for clinical chemical devices, diabetes, toxicology and cardio-renal medical devices, we: 

  • 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 device and recall classifications.
  • Review and evaluate design, test, and production data and reports from manufacturers to ensure compliance with promulgated standards and regulations.

Who We Are

The Division of Immunology and Hematology is responsible for review of immunology and hematology in vitro diagnostics devices.

What We Do

For immunology and hematology in vitro diagnostics devices, we: 

  • Coordinate, carry out, and make premarket review determinations (e.g., 510(k), PMA, HDE, DeNovo, IDE).
  • 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).
  • Coordinate, carry out, and make postmarket surveillance determinations (e.g., Medical Device Reports, Post Market Surveillance Studies, Safety Signals). 
  • Participate in development and interpretation of regulations and policies.
  • Coordinate actions on device and recall classifications.
  • Review and evaluate design, test, and production data and reports from manufacturers to ensure compliance with promulgated standards and regulations.

Who We Are

The Division of Microbiology Devices is responsible for review of microbial in vitro diagnostics, including viral respiratory, human papilloma virus, general viral, hepatitis, general bacteria, antimicrobial susceptibility, bacterial respiratory and medical countermeasures diagnostic devices.

What We Do

For microbial in vitro diagnostics, including viral respiratory, human papilloma virus, general viral, hepatitis, general bacteria, antimicrobial susceptibility, bacterial respiratory and medical countermeasures diagnostic devices, we: 

  • Coordinate, carry out, and make premarket review determinations (e.g., 510(k), PMA, HDE, DeNovo, IDE).
  • 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).
  • Coordinate, carry out, and make postmarket surveillance determinations (e.g., Medical Device Reports, Post Market Surveillance Studies, Safety Signals). 
  • Participate in development and interpretation of regulations and policies.
  • Coordinate actions on device and recall classifications.
  • Review and evaluate design, test, and production data and reports from manufacturers to ensure compliance with promulgated standards and regulations.

Who We Are

The Division of Molecular Genetics and Pathology is responsible for review of molecular genetics and pathology in vitro diagnostics, and companion diagnostics.

What We Do

For molecular genetics and pathology in vitro diagnostics, and companion diagnostics medical devices, we:  

  • Coordinate, carry out, and make premarket review determinations (e.g., 510(k), PMA, HDE, DeNovo, IDE).
  • 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).
  • Coordinate, carry out, and make postmarket surveillance determinations (e.g., Medical Device Reports, Post Market Surveillance Studies, Safety Signals). 
  • Participate in development and interpretation of regulations and policies.
  • Coordinate actions on device and recall classifications.
  • Review and evaluate design, test, and production data and reports from manufacturers to ensure compliance with promulgated standards and regulations.

Who We Are

The Division of Program Operations and Management is responsible for 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.
  • 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.

Contact Us

For specific phone numbers and email addresses for each office, see the CDRH Management Directory by Organization.

For general questions about medical devices regulation, contact the Division of Industry and Consumer Education at dice@fda.hhs.gov or 800.638.2041 or 301.796.7100.



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