OHT4: Office of Surgical and Infection Control Devices, Office of Product Evaluation and Quality
Who We Are
The Office of Health Technology 4 within CDRH's Office of Product Evaluation and Quality (OPEQ) is responsible for the total lifecycle (TPLC) review of surgical and infection control medical devices.
What We Do
For surgical and infection control 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, 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 4A within the Office of Health Technology 4 is responsible for the total lifecycle (TPLC) review of general surgery devices.
What We Do
For general surgery 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 4B within the Office of Health Technology 4 is responsible for the total lifecycle (TPLC) review of plastic and reconstructive surgery devices.
What We Do
For infection control and plastic and reconstructive surgery 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 4C within the Office of Health Technology 4 is responsible for the total lifecycle (TPLC) review of infection control devices, including sterility, personal protective equipment, disinfection and reprocessing devices.
What We Do
For infection control 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.
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.