Journal articles on the topic 'Medical regulation'

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1

Yam, Carrie H. K., Sian M. Griffiths, S. Liu, Eliza L. Y. Wong, Vincent C. H. Chung, and E. K. Yeoh. "Medical Regulation." Journal of Medical Regulation 102, no. 1 (January 1, 2016): 16–27. http://dx.doi.org/10.30770/2572-1852-102.1.16.

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The licensing and regulation of physicians is an important topic worldwide and is often tied to discussions in various countries of health care system reform. We conducted a review of current practices for regulating physicians as a key group of health care professionals in eight jurisdictions in Asia and other parts of the world in order to draw implications for the development of future regulatory policies in Hong Kong. Jurisdictions studied included Australia, Canada, China, Malaysia, New Zealand, Singapore, the United Kingdom and the United States. A literature search, supplemented by interviews, was conducted. In analyzing information gathered about global regulatory systems, we used a framework for comparing regulatory typology, developed by the RAND Europe research institute. Our review found that the jurisdictions studied exhibited both similarities and differences in terms of how physicians are regulated and by whom. As a result of our search, we were able to identify 10 key trends in international medical regulation of importance to Hong Kong as it considers reforms to its health care system overall:Changes in medical regulation are seen as a way of improving the quality of patient care.Reform of medical regulation often requires government legislation.The creation of common principles for policies, structures and the organization of regulation between professions is an emerging practice.The involvement of lay people on boards and in inquiries is increasingly common.Medical regulation is moving away from models of self-regulation and toward regulatory models that emphasize partnership between professions and the public, physicians and patients.Health care providers and institutional regulators play complementary roles in medical regulation.Regulation impacts the quality of care — not just the detection and remediation of poor performance.Investigatory and disciplinary functions are increasingly separated and organized independently of each other.Continuous Professional Development (CPD) is compulsory for physicians in many jurisdictions.Overseas medical graduates are admitted into practice in different ways from country to country. These trends are important for regulators in all countries to note as they assess the basic structure and effectiveness of their own medical regulatory systems.
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Maak, Travis G., and James D. Wylie. "Medical Device Regulation." Journal of the American Academy of Orthopaedic Surgeons 24, no. 8 (August 2016): 537–43. http://dx.doi.org/10.5435/jaaos-d-15-00403.

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3

Jarow, Jonathan P., and John H. Baxley. "Medical devices: US medical device regulation." Urologic Oncology: Seminars and Original Investigations 33, no. 3 (March 2015): 128–32. http://dx.doi.org/10.1016/j.urolonc.2014.10.004.

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4

Dietrich, Elisabeth M., and Joshua M. Sharfstein. "Improving Medical Device Regulation." JAMA Internal Medicine 174, no. 11 (November 1, 2014): 1779. http://dx.doi.org/10.1001/jamainternmed.2014.3211.

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O'Brien, Claire. "Regulation for medical genetics." Molecular Medicine Today 1, no. 6 (September 1995): 256. http://dx.doi.org/10.1016/s1357-4310(95)90923-0.

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6

Heneghan, Carl, and Mathew Thompson. "Rethinking medical device regulation." Journal of the Royal Society of Medicine 105, no. 5 (May 2012): 186–88. http://dx.doi.org/10.1258/jrsm.2012.12k030.

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7

Galgon, Richard E. "Understanding medical device regulation." Current Opinion in Anaesthesiology 29, no. 6 (December 2016): 703–10. http://dx.doi.org/10.1097/aco.0000000000000391.

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8

Kyselova, O. I., and K. O. Nadtochiy. "Features of legal regulation of labor of medical workers." Legal horizons, no. 24 (2020): 35–40. http://dx.doi.org/10.21272/legalhorizons.2020.i24.p35.

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The work of health care workers is associated with great physical and emotional stress, the need in some cases to work in difficult and life-threatening conditions. This determines some features of the legal regulation of labor relations in this area of activity: additional requirements when concluding an employment contract, preferential working hours and rest time, special rules for part-time work, etc. The specificity of the legal status of medical workers as subjects of labor law is due to both general rules and special regulations on various aspects of their activities. In addition to the general provisions of the Labor Code of Ukraine, the provisions of the law "Fundamentals of the legislation of Ukraine on health care", as well as a number of other regulations apply to medical workers who carry out professional activities. The article describes the regulations governing the employment of health workers, identifies the role of the employment contract in regulating their work, analyzes the features of the legal status of health workers as a subject of labor relations, and identifies a set of problems that arise in health care workers. in the performance of their duties. This topic is of interest not only from a scientific but also from a practical point of view, which necessitates detailed, thorough legal regulation of the work of medical workers and a more careful attitude of the legislator to this area. The urgency of the topic is due to the role of health professionals in the realization of the right of everyone to health care, guaranteed by Art. 49 of the Constitution of Ukraine.
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9

Nazarenko, G. V. "REGULATION OF COERCIVE MEASURES OF A MEDICAL NATURE." Proceedings of the Southwest State University 21, no. 2 (April 28, 2017): 164–68. http://dx.doi.org/10.21869/2223-1560-2017-21-2-164-168.

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The article is devoted to the legislative regulation of compulsory medical measures. The author shows that the legislative regulations of such measures are not limited to the criminal legislation norms. A number of articles regulating compulsory treatment are envisioned by the Law on Psychiatric Care, as well as other federal regulations. However, the legislative recommendation of coercive measures of medical nature has gaps regarding the implementation of such measures. The article reveals compulsory measures of medical nature, appointed and applied against pedophiles. The author draws attention to the restrictive conditions, the observance of which is necessary for imposition of compulsory treatment for this category of persons. The article emphasizes that the use of coercive measures of medical nature for pedophiles who have committed crimes against the sexual inviolability of minors can continue after serving their sentences if the purposes of applying coercive measures are not met. The basis for the extension of such measures is the public danger of a person suffering from sexual drive disorder. The public danger of persons listed in article 97 of the Criminal Code of the Russian Federation is the only basis for use of coercive measures of medical nature. Persons who are not dangerous are to be treated in medical organizations that provide psychiatric care on a general basis. In necessary, such persons can be send to the handicap centres.
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10

Powell, Jason L. "Doctoring Medical Governance: Medical Self-Regulation in Transition." Sociology of Health & Illness 33, no. 3 (March 2011): 502–3. http://dx.doi.org/10.1111/j.1467-9566.2011.01336.x.

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11

Novikov, Denis. "LEGAL REGULATION OF MEDICAL ACTIVITY IN RUSSIAN EMPIRE BY MEDICAL CHARTER." Inter Collegas 4, no. 2 (July 22, 2017): 52–56. http://dx.doi.org/10.35339/ic.4.2.52-56.

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Novikov D.O.The article is devoted to the study of legal regulation of county physicians’ work in zemstvo medicine. The author determined that the Medical Charter, adopted in 1905, was the first legislative framework regulating medical activities, training, salaries, labour discipline and material responsibility of physicians.Key Words: zemstvo medicine, medical activity, physicians, the Medical Charter, legal regulation, duties. ПРАВОВЕ РЕГУЛЮВАННЯ МЕДИЧНОЇ ДІЯЛЬНОСТІ В РОСІЙСЬКІЙ ІМПЕРІЇ ЗА ЛІКАРСЬКИМ СТАТУТОМНовіков Д.O.Стаття присвячена дослідженню правового регулювання праці повітових лікарів в земській медицині. Автор визначив, що прийнята в 1905 році Медична хартія була першою законодавчою базою, яка регулює медичну діяльність, підготовку, зарплату, трудову дисципліну і матеріальну відповідальність лікарів.Ключові слова: земська медицина, медична діяльність, лікарі, Медична хартія, правове регулювання, обов'язки. ПРАВОВОЕ РЕГУЛИРОВАНИЕ МЕДИЦИНСКОЙ ДЕЯТЕЛЬНОСТИ В РОССИЙСКОЙ ИМПЕРИИ ПО ВРАЧЕБНОМУ УСТАВУНовиков Д.А.Статья посвящена исследованию правового регулирования труда уездных врачей в земской медицине. Автор определил, что принятая в 1905 году Медицинская хартия была первой законодательной базой, регулирующей медицинскую деятельность, подготовку, зарплату, трудовую дисциплину и материальную ответственность врачей.Ключевые слова: земская медицина, медицинская деятельность, врачи, Медицинская хартия, правовое регулирование, обязанности.
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12

Morgan, F. J., and M. J. Brown. "Medical device regulation in Australia." Medical Journal of Australia 156, no. 11 (June 1992): 751–52. http://dx.doi.org/10.5694/j.1326-5377.1992.tb121552.x.

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13

Janarthanan, S., and Raju Kamaraj. "Medical Device regulation in U.S." Research Journal of Pharmacy and Technology 13, no. 9 (2020): 4453. http://dx.doi.org/10.5958/0974-360x.2020.00786.6.

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14

Bogle, Ian. "Self-regulation by medical profession." Lancet 352, no. 9140 (November 1998): 1626. http://dx.doi.org/10.1016/s0140-6736(98)00066-x.

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15

McAllister, P., and J. Jeswiet. "Medical device regulation for manufacturers." Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine 217, no. 6 (June 2003): 459–67. http://dx.doi.org/10.1243/09544110360729090.

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16

O’Meara, Peter, Gary Wingrove, and Michael McKeage. "Self-regulation and medical direction." International Journal of Health Governance 23, no. 3 (September 3, 2018): 233–42. http://dx.doi.org/10.1108/ijhg-02-2018-0006.

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Purpose The purpose of this paper is to describe and analyse two approaches to paramedic service clinical governance and quality management from the perspective of two groups of paramedics and paramedic managers working in North America. Design/methodology/approach A case study approach was utilised to describe and analyse paramedic service medical direction in North America and contrast this with the professional self-governance and clinical governance systems operating in other high-income countries. Researchers interviewed participants at two remote North American sites, then completed transcription and thematic analysis. Findings Participants identified three themes: first, resourcing, regulatory frameworks and fragmentation; second, independent practice facilitators and barriers; and third, paramedic roles and professionalisation. Those trained outside North America tended to identify self-regulation and clinical governance as the preferred approach to quality management. Few participants had considered paramedicine becoming a self-regulating health profession. Originality/value In North America, the “medical direction” model is the dominant approach employed to ensure optimal patient outcomes in paramedic service delivery. In contrast, other comparable countries employ paramedic self-regulatory systems combined with clinical governance to achieve the same ends. This is one of two studies to examine medical direction from the perspective of paramedics and paramedic managers.
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17

Bartlett Foote, S. "Medical technology development: limiting regulation." IEEE Technology and Society Magazine 15, no. 3 (1996): 4–9. http://dx.doi.org/10.1109/44.536293.

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18

Johnson, AG. "Self-regulation by medical profession." Lancet 352, no. 9140 (November 1998): 1626. http://dx.doi.org/10.1016/s0140-6736(05)61071-9.

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19

Singh, R. "Regulation and homeopathic medical education." Allgemeine Homöopathische Zeitung 262, no. 02 (March 21, 2017): 2–76. http://dx.doi.org/10.1055/s-0037-1601291.

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20

Nigel, Baber. "The Regulation of Medical Products." British Journal of Clinical Pharmacology 57, no. 1 (October 9, 2003): 113–14. http://dx.doi.org/10.1046/j.1365-2125.2003.01984.x.

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21

Wilmshurst, P. "The regulation of medical devices." BMJ 342, may13 2 (May 14, 2011): d2822. http://dx.doi.org/10.1136/bmj.d2822.

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22

Xiao, Cheng, Qingdong Guan, Yong Tan, Lifei Hou, and Wuxiang Xie. "Medical Plants and Immunological Regulation." Journal of Immunology Research 2018 (June 12, 2018): 1–2. http://dx.doi.org/10.1155/2018/9172096.

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23

David Banta, H. "The regulation of medical devices." Preventive Medicine 19, no. 6 (November 1990): 693–99. http://dx.doi.org/10.1016/0091-7435(90)90067-t.

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24

Limpens, Maureen. "Podosophia en Medical Device Regulation." Podosophia 29, no. 2 (May 18, 2021): 35. http://dx.doi.org/10.1007/s12481-021-00310-9.

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25

Litchman, Henry M. "Medical Professionalism and Public Regulation." Journal of Medical Regulation 90, no. 4 (December 1, 2004): 5–7. http://dx.doi.org/10.30770/2572-1852-90.4.5.

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26

O'Donnell, Michael. "The General Medical Council and the future of revalidation: Regulation, regulation, regulation." BMJ 330, no. 7505 (June 16, 2005): 1447.1. http://dx.doi.org/10.1136/bmj.330.7505.1447.

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27

Chamberlain, John Martyn. "Regulating the Medical Profession: From Club Governance to Stakeholder Regulation." Sociology Compass 4, no. 12 (December 2010): 1035–42. http://dx.doi.org/10.1111/j.1751-9020.2010.00338.x.

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28

Koh, Younsuck. "Medical ethics and self-regulation in Korean medical society." Journal of the Korean Medical Association 56, no. 4 (2013): 258. http://dx.doi.org/10.5124/jkma.2013.56.4.258.

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Kmietowicz, Zosia. "BMA rejects chief medical officer's proposals on medical regulation." BMJ 333, no. 7576 (November 9, 2006): 987.2–987. http://dx.doi.org/10.1136/bmj.39024.632569.db.

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Oelze, Ilse-Barbara, Kurt Neeser, and Elvira Müller. "PP31 Medical Device Regulation: What Is New?" International Journal of Technology Assessment in Health Care 35, S1 (2019): 42–43. http://dx.doi.org/10.1017/s0266462319001958.

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IntroductionIn 2017, the European Union (EU) commission released the final versions of the Medical Device Regulation (MDR) and In-vitro Diagnostic Device Regulation. These regulations will replace the EU directives (Medical Device Directive [MDD], In-vitro Diagnostic Device [IVDD], and Active Implantable Medical Device [AIMD]). EU regulations are effective in all EU countries at date of publication. In contrast, the EU directives must be implemented in national law first.MethodsGuidelines and respective legislation, consultation results and methods/medical device (MD) evaluations were reviewed and analyzed. Decision criteria and reasoning, assessment outcomes and potential impact on price negotiations were the main aspects for comparison.ResultsManufacturers have to be aware of the importance of clinical data for demonstrating the compliance of their products. This applies both to the approval of the products and the “post-market activities” and particularly to the “post-market clinical follow-up” for which requirements for Class I and II products need to be further developed. The MDR requires manufacturers to collect clinical data before and after approval, which could lead to excessive documentation requirements. The term “sufficient clinical data” from the MDR is unclear. A functional Eudamed specification is necessary, which enables an automated processing of relevant data. A stronger involvement in the evaluation process is needed as well as more transparency in the Joint Federal Committee (G-BA) and faster evaluation processes.ConclusionsThe MDR increases the burden especially for small businesses, and it is doubtable that the ultimate goal – improving patient safety – will be achieved. The increased demands and rising costs of the new EU MDR and bottlenecks at Notified Bodies can be a risk for the MD industry. Due to the general reduction in the remuneration for services with a high proportion of technical services, it is feared that products will be withdrawn from the market for economic reasons or that they will not be marketed.
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Targhotra, Monika, Geeta Aggarwal, Harvinder Popli, and Madhu Gupta. "Regulatory aspects of medical devices in India." International Journal of Drug Delivery 9, no. 2 (October 6, 2017): 18. http://dx.doi.org/10.5138/09750215.2147.

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<p>Today millions of patients depend on medical device based treatment for the management and diagnose of several diseases. Quality and safety of device is depends upon the regulatory guidelines. Medical device manufacturing in India should be taken seriously due to large population and the potential severity of the consequences of introducing inferior and unsafe products to the market-place. Therefore a law containing adequate guidelines of rules and regulations are required for monitoring the entry of such devices into the use in public health. The regulations define requirements of medical device design, development and manufacture to ensure that products reaching market are safe and effective. Presently in India regulatory body CDSCO is governing regulation for regulation of devices which with time, amendment introducing in the law will provide safety assurance to public health. This review provides a study on different regulatory aspects of medical device implemented in India. The present review discuss about the classification of medical devices and regulations aspects in India.</p>
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Green, James IJ. "The impact of medical device regulation on hospital doctors who prescribe and manufacture custom-made devices." British Journal of Hospital Medicine 81, no. 12 (December 2, 2020): 1–6. http://dx.doi.org/10.12968/hmed.2020.0596.

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The 1990s saw the implementation of three European directives that aimed to standardise medical device legislation. EU regulations replace and repeal these directives, to improve the safety, effectiveness and traceability of medical devices. This article discusses the implications of the Regulation (EU) 2017/745 (Medical Device Regulation) for hospital doctors who prescribe and manufacture custom-made medical devices.
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33

Jacob, Joe, Michael Moran, and Bruce Wood. "States, Regulation and the Medical Profession." British Journal of Sociology 45, no. 4 (December 1994): 705. http://dx.doi.org/10.2307/591897.

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34

Bhati, Savita, Shivani Singh, Vandana Sethi, and Vijay Bhalla. "Regulation for Medical Devices in India." Volume 1, Issue 1 : October 2015 – December 2015 1, no. 1 (November 15, 2015): 13–17. http://dx.doi.org/10.32463/rphs.2015.v01i01.03.

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In the era of competitive use of medical devices, stringent regulatory standards should be followed to ensure that the devices are safe, well studied and have minimum adverse reactions. Recently introduced guidelines and the amendment in the law will provide adequate guidance for both the manufacturers and competent authorities to manage cases efficiently and appropriately. India has emerged as one of the leaders in pharmaceutical sector. Like many other amendments in Drugs and Cosmetics Act that have boosted the global confidence in pharmaceutical sector in India, guidelines for devices will encourage the much needed research for devices in medical field. Pharmacy personnel can certainly play an important role in the regulation of medical devices. Safety, risks, effectiveness and performance of the medical devices need to be well established and regulated properly. It is necessary that the guidelines should be implemented and regulated effectively for a productive outcome to upgrade the health status of individuals.
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35

Wolinsky, Howard. "Resolution Due in Medical Software Regulation." Annals of Internal Medicine 127, no. 10 (November 15, 1997): 953. http://dx.doi.org/10.7326/0003-4819-127-10-199711150-00026.

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Mueller, E., R. Kammula, and D. Marlowe. "Regulation of “Biomaterials” and Medical Devices." MRS Bulletin 16, no. 9 (September 1991): 39–41. http://dx.doi.org/10.1557/s0883769400056037.

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On May 28, 1976, President Gerald R. Ford signed into law the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act. The purpose of the Amendments is to ensure that medical devices are safe and effective, and properly labelled for their intended use. In order to accomplish this mandate, the Amendments provide the Food and Drug Administration (FDA) with authority to regulate devices during most phases of their development, testing, and use. The FDA's approach to this regulation focuses heavily on both the pre- and post-market phases of a device's lifetime. During the pre-market phase, the FDA concentrates on providing a reasonable assurance that new devices are adequately evaluated for safety and effectiveness. Implicit in this assessment is the concept of balancing risk to benefit. If the benefits significantly outweigh the risks for the intended use, the device will most likely be approved for marketing in the United States. Since risk/benefit assessments for new technology involve considerable clinical judgment, the FDA utilizes expert panels composed of clinicians, engineers, toxicologists, and other experts familiar with the devices. These panels are often directed to review the data provided by the manufacturer to support claims for device safety and effectiveness. If the advisory panel believes the data support the manufacturer's claims, a recommendation for approval for marketing is made to the FDA. The Agency must ultimately decide whether the device is to receive approval for marketing.
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Fitzgerald, Richard. "Medical regulation in the telemedicine era." Lancet 372, no. 9652 (November 2008): 1795–96. http://dx.doi.org/10.1016/s0140-6736(08)61743-2.

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38

Godlee, F. "The scandal of medical device regulation." BMJ 345, oct24 1 (October 24, 2012): e7180-e7180. http://dx.doi.org/10.1136/bmj.e7180.

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Pietzsch, Jan B., Lauren M. Aquino, Paul G. Yock, M. Elisabeth Paté-Cornell, and John H. Linehan. "Review of U.S. Medical Device Regulation." Journal of Medical Devices 1, no. 4 (October 19, 2007): 283–92. http://dx.doi.org/10.1115/1.2812429.

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Medical device regulation plays a significant role in the design, development, and commercialization of new medical technologies. A comprehensive understanding of the various regulatory requirements and their practical implementation is thus an essential cornerstone of successful medical device innovation. In this paper, we review the background, mission, and statutory requirements of medical device regulation in the United States. As opposed to pharmaceuticals, which have been regulated since the early 1900s, medical device regulation was not enacted before 1976, when Congress signed into law the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act of 1938. The U.S. Food and Drug Administration (FDA) has implemented a risk-based classification system, which is essential in determining the regulatory pathway for a given device. Our review of the different regulatory pathways discusses the specific steps and requirements associated with each pathway, and their implications for development and testing of different types of devices. The differences in these pathways are significant, and thus require careful consideration and analysis already at early stages of development. The FDA’s Quality Systems Regulation, which outlines specific requirements for development, testing, production, and postmarket surveillance, is another important aspect of device regulation. We present its elements and relationship to design controls and other operating procedures implemented by device manufacturers, and discuss their relevance in ensuring the safety and effectiveness of marketed devices. A summary of recent additions to device regulation, implemented by the FDA to allow for adequate regulation of products that combine drugs and devices or biologics and devices (so-called combination products), completes our review. Because of the significance of device regulation for medical device innovation, we strongly support increased efforts to educate the various stakeholders involved in the medical device development process, both at the academic and professional level.
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Jiang, Nan, Julia E. Mück, and Ali K. Yetisen. "The Regulation of Wearable Medical Devices." Trends in Biotechnology 38, no. 2 (February 2020): 129–33. http://dx.doi.org/10.1016/j.tibtech.2019.06.004.

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Shuren, Jeffrey, Bakul Patel, and Scott Gottlieb. "FDA Regulation of Mobile Medical Apps." JAMA 320, no. 4 (July 24, 2018): 337. http://dx.doi.org/10.1001/jama.2018.8832.

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Curfman, Gregory D., and Rita F. Redberg. "Medical Devices — Balancing Regulation and Innovation." New England Journal of Medicine 365, no. 11 (September 15, 2011): 975–77. http://dx.doi.org/10.1056/nejmp1109094.

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Yetisen, Ali Kemal, J. L. Martinez-Hurtado, Fernando da Cruz Vasconcellos, M. C. Emre Simsekler, Muhammad Safwan Akram, and Christopher R. Lowe. "The regulation of mobile medical applications." Lab on a Chip 14, no. 5 (2014): 833. http://dx.doi.org/10.1039/c3lc51235e.

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Roach Anleu, Sharyn L. "The Legal Regulation of Medical Science." Law Policy 23, no. 4 (October 2001): 417–40. http://dx.doi.org/10.1111/1467-9930.00119.

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Sherwin-Smith, James, and Rowan Pritchard-Jones. "Medical Applications: The Future of Regulation." Bulletin of the Royal College of Surgeons of England 94, no. 1 (January 1, 2012): 12–13. http://dx.doi.org/10.1308/147363512x13189526438512.

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we define 'apps' as discrete, independent pieces of software that run on mobile devices. The use of such software on mobile devices within a health environment is not a new phenomenon – there is academic research discussing the opportunities of this technology as early as 1996. however, the proposition has only really become mainstream with the introduction of the Apple iPhone® and supporting App Store, backed by a hugely successful 'There's an app for that' advertising campaign. opening in July 2008 with a mere 500 applications available for download, the App Store now stocks around 500,000 applications and recently surpassed a staggering milestone: 15 billion downloads. Latterly it has been joined by rival application markets from Blackberry®, Microsoft® and, most successfully, AndroidTM.
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Foster, Andrew, and Peter Hawker. "Blame culture? Clinical / medical self-regulation." British Journal of Healthcare Management 6, no. 7 (July 2000): 308–9. http://dx.doi.org/10.12968/bjhc.2000.6.7.19283.

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Cowper, Andy. "Medical self-regulation: professional or amateur?" British Journal of Healthcare Management 11, no. 1 (January 2005): 4. http://dx.doi.org/10.12968/bjhc.2005.11.1.18658.

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48

Warden, J. "UK changes law for medical regulation." BMJ 317, no. 7173 (December 12, 1998): 1615. http://dx.doi.org/10.1136/bmj.317.7173.1615a.

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Kessler, David A., Stuart M. Pape, and David N. Sundwall. "The Federal Regulation of Medical Devices." New England Journal of Medicine 317, no. 6 (August 6, 1987): 357–66. http://dx.doi.org/10.1056/nejm198708063170606.

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Donnelly, P. "States, Regulation and the Medical Profession." Journal of Epidemiology & Community Health 47, no. 6 (December 1, 1993): 511. http://dx.doi.org/10.1136/jech.47.6.511-b.

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