The Center for Devices and Radiological Health (CDRH) is a branch of the U.S. Food and Drug Administration (FDA). But many may wonder precisely what this entails. What are the duties of this agency and the guidelines along which those duties are carried out? To what rules and legislation is the CDRH subject? What sort of work do they do? The article below offers information about the regulatory agency and seeks to satisfy these questions.
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General Duties and Purviews
The CDRH, like its parent agency, the FDA, is tasked with protecting and promoting the health of the American public. But their role is specifically focused on the development, use, and further understanding of radiation-emitting devices. In essence, while they are a regulatory agency, the Center for Devices and Radiological Health also researches the safe operation and application of new devices and technologies that use radiation in therapeutic doses.
It is also a part of their mission to enhance the public understanding of these devices and to provide salient information to patients, healthcare agencies and practitioners, and private caregivers. Regulatory science—which is the systematic exploration of how, when, and in what ways a device or substance may be used or marketed while also enhancing the safety, health, and general wellbeing of any portion of the population—is a significant part of the work they do.
They design regulatory processes for both existing technologies and new devices. However, their mission is to continuously assess radiological apparatuses used in medical procedures for quality and safety, help develop new technologies with higher efficiency and safety and provide those device developers with ways in which they can adhere to the highest standards of regulation without trouble or delay.
Understanding and Sharing
Because technologies must be investigated in order to fully understand their potential implications and elaborations, the CDRH employs scientists and technology experts whose primary duty is to better understand these factors. However, the CDRH doesn’t just use the fruits of their labors to smooth regulatory pathways for foreign inventors and investors. They also provide detailed information and the products of their science-based inquiries to the general public and the medical communities.
This transparency and commitment to scientific integrity serve to promote public trust in devices that are manufactured within the US. It also helps medical professionals offer the latest and most effective treatments for diseases or conditions responsive to therapeutic doses of radiation.
Another aspect of the CDRH’s commitment to transparency is process-based. In order to help the public better understand what they do and how it’s done, the CDRH and its parent organization, the FDA, provide detailed summaries of policies and decision-making processes. Available on their webpage are regularly updated communications about changes to the system of approval and regulation, different devices they have evaluated, official communications about their work, and reclassifications of existing devices and therapeutic technologies.
While it may not often seem an important job, regulating devices that emit radiation in large or small amounts is an important part of caring for public health. By monitoring therapeutic radiation devices, examining new technologies, and holding themselves to the highest standard of integrity and openness, the Center for Devices and Radiological Health (CDHR) ensures that only the most efficient, safest technologies are offered to the public and healthcare providers.
