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Artificial Intelligence and Medical Devices
Published in Frank M. Groom, Stephan S. Jones, Artificial Intelligence and Machine Learning for Business for Non-Engineers, 2019
In the United States, the FDA regulates the sale of medical devices and monitors the safety of all regulated medical products. Medical devices are categorized by the FDA into three classes – Class I, II, or III. They are classified based on their risks to patients and the regulatory controls required to provide adequate assurance of safety. Class I devices pose the lowest level of risk to the user, and Class III devices pose the highest risk. Examples7 of devices across the three classes are: ■ Class I: bandages, I.V. stand, sunglasses■ Class II: syringe, surgical mask, powered wheelchair■ Class III: heart valves, implantable neuromuscular stimulator
FDA Regulations
Published in Richard C. Fries, Handbook of Medical Device Design, 2019
A medical device is any article or health care product intended for use in the diagnosis of disease or other condition or for use in the care, treatment, or prevention of disease that does not achieve any of its primary intended purposes by chemical action or by being metabolized.
Regulatory Affairs for Medical Device Clinical Trials in Asia Pacific
Published in Jack Wong, Raymond K. Y. Tong, Handbook of Medical Device Regulatory Affairs in Asia, 2018
The most obvious difference would be the product types involved in the trial. Medical devices vary in complexity and would include a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of disease or abnormal physical condition. Medical devices with pharmaceutical components may be categorised as a combination product or a medical device or a pharmaceutical product. Interestingly, some medical devices are classified and regulated as drugs in a few countries. The classification of the investigational medical device should be clarified upfront by the sponsor with the relevant regulatory bodies as this would influence the requirements for conducting the clinical trial.
Cardiac implantable electronic devices and cybersecurity
Published in Expert Review of Medical Devices, 2021
Bhakti Patel, Amgad N. Makaryus
Medical devices, including cardiac technology, are often linked with the internet and hospital networks in order to efficiently communicate patient care and data. The assets of internet-connected medical technology are mitigated by the potentially significant risks, such as data breach and cyberthreats. These risks can have an impact on the safety and wellbeing of the patient relying on the medical device. The U.S. Food and Drug Administration (FDA) is predominantly responsible for ensuring that medical devices are safe and effective. In order to remain in control of cybersecurity threats, the FDA is involved with the newest technological advances in research as well as collaborations with stakeholders on public health issues [1]. Cybersecurity is an especially important concern in the field of cardiology as there are numerous cardiac technologies available with remote internet connection. We undertook a literature review focusing on the history, progression, and improvements in the monitoring of cybersecurity vulnerabilities surrounding cardiovascular medical devices.
LSPR detection of extracellular vesicles using a silver-PDMS nano-composite platform suitable for sensor networks
Published in Enterprise Information Systems, 2020
D. Raju, S. Bathini, S. Badilescu, R. J. Ouellette, A. Ghosh, M. Packirisamy
In the future, the global system of medical devices will comprise a multitude of devices and applications using sensors, actuators, microcontrollers, mobile-communication devices, and healthcare will be delivered more effectively and at lower cost. It will include not only the collection of patient data for preventive care but also diagnostics and treatment results. Automation and real-time aspects will reduce errors and improve quality and efficiency. Today, wireless sensor-based systems gather medical data that were never before accessible and deliver care directly to patients. Healthcare is based now on a network of devices that connect directly with each other to capture and share data through a server in the cloud and then on to caregivers. Data is captured via sensors, analysed, and medical professionals can wirelessly access the information and make treatment recommendations. Remote monitoring means that more patients will have access to adequate healthcare. Progress in sensor technology will in this way change the role of hospitals, outpatient sites and homes. Within the medical world there is an intersection between information technology and biotechnology, and increasingly the role of sensors, signal transducers, actuators will broaden too. Some examples of new generation medical sensors indicate new roles that these devices will have in many areas of health care.
Regulatory convergence of medical devices: a case study using ISO and IEC standards
Published in Expert Review of Medical Devices, 2018
Kuniki Imagawa, Yoshiaki Mizukami, Seiko Miyazaki
In the USA, medical devices are regulated under the Federal Food, Drug, and Cosmetic Act, which gives authority to the Food and Drug Administration (FDA) to regulate food, drugs, medical devices, biologics, cosmetics, and radiation-emitting products in the USA. Medical devices are overseen by the Center for Devices and Radiological Health (CDRH), a branch of the FDA. The FDA publishes regular notices in the Federal Register about recognized consensus standards and their recognition and use [16]. In the FDA Guidance titled ‘Guidance for Industry and FDA Staff. Recognition and Use of Consensus Standards’ [17], the FDA describes that when the recognized standard includes specific acceptance criteria that describe relevant performance characteristics of that specific medical device, conformity to the recognized standard should minimize the amount of data and documentation needed in the 510(k) submission to demonstrate substantial equivalence. Basic information on regulations applicable to the EU and outside the EU, including the USA, were previously reported in detail [18,19].