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• W4383900635 abstract "To a great extent, consensus standards are documents that form the foundation of science, health, and technology in society.1 They have ensured that everything from infrastructure to consumer products works together in a safe, reliable manner. Standards are used and adopted around the world by governments, corporations, and non-governmental organizations.2The language and requirements within standards are unequivocally part of frameworks that have been agreed upon through a fair and balanced consensus process. This transparent, open consensus process is what makes standards particularly unique. For the Food and Drug Administration's Center for Devices and Radiological Health (CDRH), which is responsible for regulating medical devices in the United States, FDA-recognized standards include product specifications, test methods, guidelines, and performance criteria. These standards are tools that contribute to the center's regulatory capabilities to oversee the total product life cycle of devices and support the FDA's mission to protect the public health of the United States.Back when I was a mechanical engineering student at the Rochester Institute of Technology, I was constantly bombarded by standards. It seemed there was a standard for everything, complete with a never-ending list of confusing designations. How was I to remember all of these editions, revisions, and standards developing organizations?My classmates and I always saw standards as a way to add legitimacy to the learning process and as a tool that took our projects from ideas to the test bench. What was not apparent to us was that standards could be viewed from a standards management perspective. Standards could be found across multiple industries and were woven into the very fabric of the American economy, touching on manufacturing, trade, technology and innovation, and intellectual property. They also were an integral part of our competitive strategy. You can imagine how an engineer, having only taken three non-technical classes, might be completely unaware of these other affected areas.Today, the complex aspects of standards designations still have not changed, but I have become enamored of the regulatory ecosystem of standards since joining the FDA Standards and Conformity Assessment Program (S-CAP) less than two years out of university. One of the things I love most about working in a government agency like the FDA is our mission to protect and promote public health.3 I believe it is in the public interest to have standards behind technology development in order to prioritize the safety and effectiveness of medical devices across the total product life cycle.Standards, when properly utilized to support regulatory decisions, benefit manufacturers, suppliers, and firms economically. They can streamline product development, ensure quality, promote trade, and improve supply chains. Standards are increasingly seen as a tool for neutral cooperation and as a means of effecting beneficial systemic solutions in modern society.Moreover, standards have been important for carrying out the Sustainable Development Goals of the United Nation (UN), providing a way for nations to define, implement, and measure systems and technologies. Notably, with respect to the field of global development, two international standards- developing organizations, the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC), jointly released guidance on gender- responsive standards that seeks to advise developers on assessing diversity, physical differences, and gender roles. The guidance is intended to ensure that standards support safety and efficacy for both men and women, thus acknowledging that there are still significant gaps in the effort to achieve gender balance.4One of the things I appreciate is that S-CAP's role in standards and conformity assessment is promulgated under Section 514 (c-d) of the Federal Food, Drugs and Cosmetic Act (21 U.S.C. § 360d).5 The level of integrity needed to conform with Section 514 must necessarily be high; consequently, S-CAP must work to recognize standards and ensure they are fit for their intended regulatory purpose, whether it is to allow manufacturers to declare conformity to performance standards or develop conformity assessment tools. For these reasons, the FDA has recognized more than 1,450 consensus standards to date and supports 400-plus staff serving as liaisons to national and international standards committees. These liaisons continually work to engage with stakeholders and revise standards to become “regulatory ready” such that they can be readily used by FDA to support the total product lifecycle, from pre-market review to post-market surveillance activities.At S-CAP, one of my duties is to promote and manage standards development within the material sciences and tissue engineered products specialty task groups (STGs), a set of device areas developed by S-CAP that divide medical device standards into nineteen different specialties.6 Most recently, I co-led the launch of the CDRH Emerging Standards Professionals community, setting forth a pipeline to support new and experienced scientific and regulatory staff to become standards professionals within the center. Through it all, many of the skills and personality traits I've had to hone include being resourceful, charismatic, and socially and emotionally intelligent. Putting these skills to work to form communities and drive scientific consensus is critical to becoming a leader in standards.Developing specific initiatives and agendas is important because technical experts and standards developers have limited time and resources to work on standards research and development. Beyond this, it is beneficial for an emerging professional to build technical expertise in a domain, not only to fully appreciate the requirements but also to grasp the social and regulatory challenges to using standards effectively and responsibly to promote a common good.Finally, with respect to emerging professionals, my experience in the standards profession has been an unexpected journey, with a world full of knowledge and people to meet. Amusingly, I can also no longer describe my job in standards at a cocktail mixer in a succinct sentence. After two years of reading about the law, policies, and our research, I can say I've only scratched the surface of standards. The fact is that standards are a key element in the public-private partnership and have social, commercial, and technological consequences for how innovative health technologies are developed.Disclaimer: The views expressed herein are solely the opinions of the author and do not reflect the viewpoints of the Food and Drug Administration, U.S. Department of Health and Human Services, or their affiliates." @default.
• W4383900635 created "2023-07-12" @default.
• W4383900635 creator A5053539016 @default.
• W4383900635 date "2022-12-14" @default.
• W4383900635 modified "2023-10-07" @default.
• W4383900635 title "Consensus Standards: A Framework for the Future of Science, Health, and Technology" @default.
• W4383900635 doi "https://doi.org/10.58831/2831-7920-1.5.8" @default.
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