Charge to the CDRH Research Review Subcommittee
The Center for Devices and Radiological Health (CDRH) is responsible for promoting public health by facilitating medical device innovation and protecting public heath by assuring that medical devices are safe and effective. CDRH regulates a wide range of products from tongue depressors to cardiac pacemakers, imaging equipment to in vitro diagnostic devices.
CDRH Vision for Regulatory Science: CDRH’s regulatory science research program is designed to be proactive, by anticipating regulatory and public health issues, and responsive, by focusing on important and emerging public health and regulatory issues. Our research is highly relevant to Center’s regulatory needs, collaborative, of high quality, and integral to the Center’s regulatory mission and public health portfolio. Our regulatory science research portfolio consists of multidisciplinary laboratory research programs in our Office of Science and Engineering Laboratories (OSEL), multidisciplinary regulatory research projects in pre- and post-market offices, and epidemiological research in our Office of Surveillance and Biometrics (OSB). The regulatory science research is conducted in-house and through collaborations with other Federal organizations, other FDA Centers as well as industry, health care professional organizations, and academia both in the U.S. and abroad. This research provides CDRH with scientific expertise, tools, standards, methodologies, and data to support science-based decision-making and policy development as well as help industry develop, assess, and manufacture new devices and technologies more quickly and efficiently.
Charge to the FDA Science Board: The FDA Science Board is charged with conducting a review to assess how CDRH’s regulatory science portfolio can best anticipate and address emerging medical devices and new public health concerns from currently marketed devices. The subcommittee should consider the broad scientific disciplines and technologies that CDRH needs to support its regulatory functions and decision making.
Specifically, the Board is asked to address the following questions:
- What, if any, changes should CDRH make to its regulatory science research portfolio to best accomplish our public health mission?
- Given the breadth of devices before us and what is anticipated in the future, what should be CDRH’s capacity for conducting or collaborating on regulatory science research?
- Assess any gaps in regulatory science capabilities or expertise.
- Identify scientific areas where CDRH should make programmatic and resource changes.
- Identify opportunities for collaboration to better leverage CDRH’s regulatory science programs.
- A growing challenge for CDRH is to assure that the Center is optimally prepared to facilitate the development, review, and monitoring of new and emerging medical technologies. What methods, such as horizon scanning and research prioritization, should be used and how could they best be employed to optimally preparing the Center to address new and emerging medical devices?