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  6. OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices, Office of Product Evaluation and Quality
  1. CDRH Offices

OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices, Office of Product Evaluation and Quality

Who We Are

The Office of Health Technology 3 within CDRH's Office of Product Evaluation and Quality (OPEQ) is responsible for the total lifecycle (TPLC) review of reproductive, gastro-renal, urological and general hospital devices. We are also responsible for the CDRH Human Factors program.

What We Do

For reproductive, gastro-renal, urological, and general hospital medical devices and human factors, 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, etc.), compliance and quality programs (e.g., Establishment Inspection Report, Regulatory Audit Reports, Recalls, Allegations of Regulatory Misconduct, Labeling, Enforcement Actions, etc.), and surveillance programs (e.g., Medical Device Reports, Post Market Surveillance Studies, Safety Signals, etc.).
  • Serve as the primary source for scientific and medical expertise with regard to safety and effectiveness of medical devices throughout the total product lifecycle.
  • Work closely with other offices on classification and reclassification activities, and the development of guidance documents.
  • Provide initial support for questions related to regulatory programs in response to specific 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.

Office Organization

Who We Are

The Division of Health Technology 3A within the Office of Health Technology 3 is responsible for the total lifecycle (TPLC) review of renal, gastroenterology, obesity and transplant devices.

What We Do

For renal, gastroenterology, obesity and transplant 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 post market 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.

Who We Are

The Division of Health Technology 3B within the Office of Health Technology 3 is responsible for the total lifecycle (TPLC) review of reproductive, gynecology and urology devices.

What We Do

For reproductive, gynecology and urology 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 post market 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.

Who We Are

The Division of Health Technology 3C within the Office of Health Technology 3 is responsible for the total lifecycle (TPLC) review of drug delivery and general hospital devices and the OPEQ human factors program.

What We Do

For drug delivery and general hospital devices, and OPEQ's human factors program engineering, 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 post market 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.

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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