Radiological health involves the safe use of radiation in medical diagnosis, treatment, and industrial applications. Its goal is to minimize unnecessary radiation exposure for patients, healthcare workers, and the public. Regulation is critical for managing the risks of ionizing radiation (such as cancer risks from excessive exposure). As we navigate through 2025, staying informed about these regulations has never been more important for healthcare facilities, manufacturers of radiation-emitting devices, and radiation safety professionals. Recent streamlining efforts by regulatory agencies have significantly altered compliance requirements, creating both opportunities and challenges for stakeholders in this space.
Key Federal Agencies and Their Specific Roles
Radiological health regulation is governed by several different federal agencies, each responsible for its own aspect:
- Food and Drug Administration (FDA): The FDA’s Center for Devices and Radiological Health (CDRH) regulates all radiation-emitting electronic products—both medical and non-medical—under the Radiation Control for Health and Safety Act of 1968 and the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act. These include X-ray machines, CT (computed tomography) scanners, and mammography equipment, ensuring they operate within safety limits to minimize unnecessary radiation exposure.
- Environmental Protection Agency (EPA): EPA’s mission is to protect people from radiation hazards through its regulations, which include establishing environmental standards for radiation. Its technical reports depict dose and risk assessments, which standardize federal guidance and are used by federal and state agencies in developing regulations. According to their guidance page, Federal Guidance for Radiation Protection | US EPA, this role is also crucial in the management of radiation in soil, water, and air.
- Nuclear Regulatory Commission (NRC): The NRC oversees the possession and use of byproducts, sources, and special nuclear materials in the use of medicine, especially through its Medical Use Program found in 10 CFR Part 35. NRC regulates the medical use of radioactive materials, including radiopharmaceuticals and brachytherapy sources.
- Occupational Safety and Health Administration (OSHA): OSHA sets standards for occupational exposure to ionizing radiation under 29 CFR 1910.1096 to protect the health and safety of workers. This standard, virtually unchanged since 1971, lays out permissible limits for exposure and mandates that employers develop monitoring and protective measures that align with more contemporary guidance from the NRC and International Commission on Radiological Protection.
Navigating Compliance: Practical Steps and Challenges
These regulations can be complex to comply with, particularly for healthcare facilities, and require a well-structured approach:
- Radioactive equipment compliance and licensing: Facilities must ensure all radiation-emitting devices meet FDA performance standards, conducting regular maintenance and calibration. Facilities using radioactive materials must obtain licenses from the NRC or an Agreement State. The license specifies the types, quantities, and storage conditions of the materials. This process involves thorough reviews of qualifications, facilities, and safety programs, as detailed in NRC guidance.
- Radiation Safety Programs: Developing a radiation safety program is essential for compliance with NRC and OSHA requirements. This includes training staff to follow handling procedures, response to emergency communication, and maintaining records; A Radiation Safety Officer (RSO) must be designated for each facility and approved by the relevant regulatory authority.
- Quality assurance: Imaging devices undergo frequent quality control tests to determine if they are both accurate and safe, including daily calibration for CT scanners and tests of the X-ray machines every few months, according to the specific guidelines. Notably, 25% of healthcare facilities fail their initial radiological inspections—often due to documentation gaps or outdated calibration protocols. Robust regulatory infrastructure and proactive compliance strategies can significantly mitigate these risks.
- Continuous education: Professionals must remain informed of regulatory changes via continuing medical education, attending workshops, and interacting with professional organizations. This is important as regulations evolve, particularly with advanced technologies such as AI in medical imaging, which is receiving increased regulatory scrutiny.
One of the most challenging aspects of radiological health compliance lies in understanding where different regulatory frameworks intersect. For example, the FDA regulates the design and safety of devices used to manufacture radioisotopes for nuclear medicine, while the actual handling and use of these materials are governed by state regulations. Furthermore, the EPA sets general radiation protection standards while the NRC and Agreement States address licensing requirements.
Healthcare facilities and industrial users of radiation-emitting equipment must adhere to multiple regulatory authorities; compliance strategies must encompass federal regulations and state requirements- creating an intricate regulatory landscape requiring careful consideration and scrutiny.
Conclusion
Navigating US regulations in radiological health is essential for ensuring safety and quality in healthcare delivery. To ensure safety and compliance, companies must navigate the evolving regulatory landscape set by the FDA, EPA, NRC, and OSHA. As technology evolves, staying informed about emerging trends like AI in radiology will be crucial for future compliance. Staying informed not only ensures compliance but also contributes to safer, more effective patient care- an objective that benefits everyone involved in the healthcare ecosystem.
At DDReg Pharma, we help companies stay ahead of regulatory changes in radiological health by offering expert guidance on compliance, clinical trial applications, and FDA submissions.
For expert guidance on FDA product registration, connect with our experts today. Read more about USFDA regulations from the experts here: Implementing a Quality by Design (QbD) Approach in Regulatory Submissions