OHT8: Office of Radiological Health
Who We Are
The Office of Health Technology 8: Office of Radiological Health within CDRH's Office of Product Evaluation and Quality (OPEQ) is responsible for mammography quality standards, electronic product radiation control, and the total product lifecycle (TPLC) activities for the radiological diagnostic imaging and radiation therapy medical devices programs.
What We Do
For radiological health 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, De Novo, 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).
- 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 Center and Agency officials on Office programs and policies.
- Participate in the development of national and international consensus standards, and voluntary guidelines through interaction with national and international standards committees.
- Determine policy for and oversee the Electronic Product Radiation Control (EPRC) program, and the Mammography Quality Standards Act (MQSA) program.
- Apply EPRC regulations (e.g., Recalls, Variances, Exemptions, Notifications of Failure to Comply, Notifications of Defect, Accidental Radiation Occurrences) to protect the public from hazardous and unnecessary exposure to radiation from medical and non-medical electronic products.
- Implement the Mammography Quality Standards Act (MQSA) including annual inspections, compliance actions, consumer outreach, training of new inspectors, and oversight of accrediting bodies and states as certifiers.
Office Organization
Who We Are
The Division of Mammography Quality Standards is responsible for ensuring all women have access to quality mammography through implementation of the Mammography Quality Standards Act (MQSA).
What We Do
For Mammography Quality Standards Act (MQSA), we:
- 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 Health Technology 8B is responsible for the total lifecycle (TPLC) activities for diagnostic X-ray systems, radiation-emitting electronic products, and radiological imaging software products.
What We Do
For the total lifecycle (TPLC) activities for diagnostic X-ray systems, radiation-emitting electronic products, and radiological imaging software products, we:
- Coordinate, carry out, and make premarket review determinations (e.g., 510(k), PMA, HDE, DeNovo, IDE) for diagnostic X-ray systems, radiation-emitting electronic products, and radiological imaging software products.
- 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 classification.
- Review and evaluate design, test, and production data and reports from manufacturers to ensure compliance with promulgated standards and regulations.
- 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.
Who We Are
The Division of Health Technology 8C is responsible for the total lifecycle (TPLC) activities for mammography, ultrasound, magnetic resonance, nuclear medicine, and radiation therapy devices.
What We Do
For total lifecycle (TPLC) activities for mammography, ultrasound, magnetic resonance, nuclear medicine, and radiation therapy devices, we:
- Coordinate, carry out, and make premarket review determinations (e.g., 510(k), PMA, HDE, DeNovo, IDE) for mammography, ultrasound, magnetic resonance, nuclear medicine, and radiation therapy devices.
- 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 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 dice@fda.hhs.gov or 800.638.2041 or 301.796.7100.