Scientific Definition of Medical Device Regulation

    "Regulatory Science" is commonly translated in China as "regulatory science". The term first appeared around 1970. The term first appeared in an internal memorandum on regulation from the U.S. Environmental Protection Agency (EPA), which had not long been established. At first, the use of the term was more controversial.

      As issues such as nuclear energy risks, pesticide use, waste disposal, mine safety, and chemical releases have become more prominent in society, it has become more important than ever for the government and the public to know in advance whether new laws, upcoming regulations, and related lawsuits will be determined to be reasonable, and what impacts and outcomes are expected. And in order to make these predictive processes practically actionable, one important tool needs to be used: regulatory science. So, in 1985, Dr. Moghissi founded the Institute for Regulatory Science (IRS) in the United States. The Institute is a non-profit scientific research and educational organization, which has attempted to define "Regulatory Science" several times, including: (1) Regulatory Science consists of the scientific basis for policy making; (2) Regulatory Science consists of the scientific information used for policy making, including regulatory, legislative, and judicial decision making; (3) Regulatory Science consists of the scientific information that makes up regulatory, legislative, and judicial decisions; and (4) Regulatory Science consists of the scientific information that makes up regulatory, legislative, and judicial decisions. science consists of the disciplines that form the scientific basis of regulatory, legislative and judicial decision-making; and (iv) regulatory science consists of the science of applications in policy-making.

     Based on the synthesis of the above, Moghissi et al. provide the following definition of generic regulatory science: regulatory science is an interdisciplinary and multidisciplinary discipline that develops and applies scientific methods, tools, and processes developed in other related disciplines in regulatory and policy decision-making. It forms the scientific basis and tools for decision-making. Simply put, regulatory science consists of the science applied in the decision-making process.

     A key feature of regulatory science is the prediction of future events. Laws and regulations pertaining to food, drugs, the environment, the economy, and many other areas need to anticipate potential impacts in order to promote favorable developments and avoid undesirable consequences. Regulatory science can also be used to assess the validity of other policy decisions. The U.S. Food and Drug Administration (FDA) took the lead in defining and applying "Regulatory Science" in the context of departmental agency functions in 2004, with the following definitions in the context of the FDA's work on food and drug regulation: 1) Regulatory Science is the process developed to assess the safety, efficacy, quality, and performance of all FDA-regulated products, Regulatory science is the science of developing new tools, standards, and methods to assess the safety, effectiveness, quality, and performance of all FDA-regulated products; (ii) Regulatory science is the application of scientific methodologies to improve the research and development, review, and oversight of drugs, biologics, and medical devices, which require registration and licensure approval prior to their application; and (iii) Regulatory science facilitates the development, evaluation, and application of new tools, methods, and standards that support a better understanding of, and improve, product safety, effectiveness, quality, and performance, effectiveness, quality, and performance throughout the product life cycle.

    As it enters the 21st century, FDA faces a number of public health challenges, including dramatic product changes due to rapid advances in science and technology, explosive growth in knowledge and research capacity in many areas, and globalization. To meet these challenges, which are more complex than in the past, it is necessary to build on the theoretical foundation of topical design and conduct more exploratory research. As a result, FDA has defined, systematized, and shaped the content and development strategies of the discipline of Regulatory Science.

     Specifically for medical device regulatory science, mainly involved in the implementation of medical device product regulation, dissemination of relevant information to the community, as well as the establishment of the development of regulations and guidelines, etc. FDA Center for Medical Devices and Radiological Health (CDRH) for medical device products "regulatory science" is defined as "a science that serves to regulate, and to provide guidance to the public. The science of regulation, through the development and application of new tools, standards, and methods for assessing the safety, efficacy, quality, and performance of medical devices throughout their lifecycle, to ensure that regulatory decisions related to medical devices are well-informed and have the desired favorable public health impacts". Relevant regulatory decisions include pre-market review, post-market surveillance, and public disclosure. The science of medical device regulation encompasses multiple disciplines, including engineering, medicine, chemistry, toxicology, epidemiology, statistics, and social sciences.

     [This article is excerpted from the chapter "Outline of Medical Device Regulatory Science" in Biomaterials and Tissue Regeneration (Fu Xiaobing et al., eds., People's Health Publishing House, to be published).]