OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices, Office of Product Evaluation and Quality Also referred to as: OHT1
Who We Are
The Office of Health Technology 1 within CDRH's Office of Product Evaluation and Quality (OPEQ) responsible for the total lifecycle (TPLC) review of ophthalmic, anesthesia, respiratory, ear, nose and throat (ENT) and dental medical devices.
What We Do
For ophthalmic, anesthesia, respiratory, ear, nose and throat (ENT) and dental 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.).
- 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 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 1A within the Office of Health Technology 1 within CDRH's Office of Product Evaluation and Quality (OPEQ) is responsible for the total lifecycle (TPLC) review of ophthalmic medical devices.
What We Do
For ophthalmic medical devices, we:
- 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 post market 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 post market 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.
Who We Are
The Division of Health Technology 1B within the Office of Health Technology 1 within CDRH's Office of Product Evaluation and Quality (OPEQ) responsible for review of dental devices.
What We Do
For dental medical devices, we:
- 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.
Who We Are
The Division of Health Technology 1C within the Office of Health Technology 1 within CDRH's Office of Product Evaluation and Quality (OPEQ) responsible for review of ear, nose and throat (ENT), sleep disordered breathing, respiratory and anesthesia devices.
What We Do
For review of anesthesia, respiratory and ear, nose and throat (ENT) medical devices, we:
- 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.
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 [email protected] or 800.638.2041 or 301.796.7100.