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Requirements and Test Methods for Injectable Solutions and Medical Devices
Published in Thomas A. Barber, Control of Particulate Matter Contamination in Healthcare Manufacturing, 1999
The FDA, through the Center for Devices and Radiological Health (CDRH), groups devices in three general classes (I—III) based generally on their complexity and degree of risk and benefits. Class I devices require the least control, being simplest in design and having minimal potential for user harm. This category includes exam gloves, elastic bandages, and hand-held surgical instruments. Class II devices include powered wheelchairs, infusion pμmps, and surgical drapes; they are subject to the general controls applied to Class I, as well as special controls such as labeling requirements and postmarket surveillance. Class II devices are subject to premarket notification and GMP. Class III devices are usually those that sustain hμman life and may have an inherent high risk level with regard to patient injury. These are subject to premarket approval or the 510(k) process, as well as general and special controls. Pacemakers, < 6 mm vascular grafts, and some implants are in this class, as well as many IV solution and blood contact devices.
United States Medical Device Regulatory Framework
Published in Jack Wong, Raymond K. Y. Tong, Handbook of Medical Device Regulatory Affairs in Asia, 2018
The FD&C Act also requires FDA to classify devices intended for human use into one of three regulatory categories (Class I, Class II, and Class III). The tiered classification is based on risk, including the associated level of control necessary to mitigate that risk (i.e., general controls, special controls, and/or premarket approval):Class I: General ControlsClass II: General and Special ControlsClass III: General Controls and Premarket Approval
Biodistribution, Toxicity and Regulatory Considerations of Dendrimers
Published in Neelesh Kumar Mehra, Keerti Jain, Dendrimers in Nanomedicine, 2021
Anisha D’Souza, Pratikkumar Patel
For new medical devices, clinical trials can be initiated after submitting an ‘investigational device exemption.’ Class II and Class III devices mandate the manufacturer to file an FDA 510k application or Premarket Notification with the FDA. A ‘substantially equivalent device to the already marketed one’ does not require a review as a Class III device and can obtain 510(k) approval. Gadomer-17, a MRI contrast linked dendrimer, is under clinical trials for blood pool imaging agents by Bayer Schering Pharma AG, Germany. The imaging agent is similar to the diagnostic agent Gd-DTPA-PLL prototype (DTPA-diethylene triamine penta-acetic acid; PLL-polylysine) but with a superior rate of elimination (Kannan et al. 2014).
Evolution of China regulatory guidance on the clinical evaluation of medical devices and its implication on pre-market and post-approval clinical evaluation strategies
Published in Expert Review of Medical Devices, 2023
Over the last 20 years, the medical device industry in China has been growing rapidly, triggering the rapid evolution of regulatory requirements for or guidance on the clinical evaluation of medical devices. These regulatory requirements are more complex than those for drugs because of the diverse clinical, technical, and biological characteristics and various risk levels of medical devices. Regulatory authorities categorize medical devices into three classes based on their risk levels: Class I, low risk; Class II, intermediate risk; and Class III, high risk. Guo et al. (2016) reported that the proportions of Class I, II, and III devices defined by the China National Medical Products Administration (NMPA; formerly known as China Food and Drug Administration [CFDA]) were 21%, 54%, and 25%, respectively [1]. However, changes in the regulatory requirements for medical device clinical evaluation over the last 20 years have focused on Class II and III devices.
Force-based stiffness mapping for early detection of breast cancer
Published in Inverse Problems in Science and Engineering, 2021
Lorraine G. Olson, Robert D. Throne, Emily I. Rusnak, Jonathan P. Gannon
Studies related to ‘tactile imaging’ or ‘mechanical imaging’ [23–28] take a fundamentally different approach. Here a transducer (similar to an ultrasound wand) is manually scanned over the breast surface. The transducer measures reaction pressures, and the patterns overlap to form a full map of the reaction pressures. Sarvazyan et al. have further developed this approach and marketed it as the medical device ‘SureTouch’ [29–37]. Surface stress patterns are measured by a wand which is scanned over the surface of the breast. From this data, a semi-empirical approach is used to create a 3D image of the breast [35]. This device is now FDA-cleared as a Class II medical device and marketed for clinical use. The main audience for the device is women who refuse regular mammographic screening, women under 40 who seek screening, and women who have contraindications to radiation and severe breast compression [38].
Medical textiles
Published in Textile Progress, 2020
Medical devices within the United Kingdom fall into one of three categories. Class I medical devices have a low to moderate risk to the patient. Class II medical devices pose a moderate to high risk to the patient/user whilst Class III medical devices are those with a high risk to the patient/user. As the risk to the patient/user increases then the regulatory requirements for licensing and the end product also increase. Regardless of the risk level, each of these categories is governed by a different European Union directive: