Abstract
Abstract Introduction The regulatory framework and standardized assay methods for classical biomaterials and implantable devices are harmonized at the international level, based on the risk assessment. However, innovative products need the development of more appropriate assay methods and streamline regulatory and scientific evaluation to encourage innovation and ensure more expedite delivery of novel, safe and effective innovative medical devices to patients. The aim of this work is to review the latest focus on the conflicting issues that are involved in the evaluation of recently developed biomaterials and medical devices. Methods This paper is based on a review of the relevant academic literature regarding the field of medical devices over the last ten years (2008-2017). A systematic search was conducted in Medline data base for articles using “medical devices” + “regulations” + “innovation” in the title or abstract. Discussion There is the widespread perception that research and marketing of innovative medical devices are moving swifter, even more so than the issues concerning evaluation methods and regulations. Collaboration among all the stakeholders could contribute to overcome the existing problems in medical device innovation.
Highlights
The regulatory framework and standardized assay methods for classical biomaterials and implantable devices are harmonized at the international level, based on the risk assessment
The mission of the national regulatory agencies for medical devices is to protect patients and the whole society from unsafe products, in balance with the speed needed for the introduction in the market of innovative products which can be beneficial to patients, those promoting public health (Curfman and Redberg, 2011; Krouse, 2015; Krucoff et al, 2012; Stern, 2017)
The first regulation for devices intended for human use was developed by the Device Amendments of 1976 of the Food and Drug Administration (FDA) of the United States (Center for Devices and Radiological Health, 2011; Lind, 2017; Van Norman, 2016; Wizemann, 2010) and until the late 1990s the FDA held a remarkable position among national regulatory agencies all around the world
Summary
The regulatory framework and standardized assay methods for classical biomaterials and implantable devices are harmonized at the international level, based on the risk assessment. The regulatory framework and standardized assay methods for medical devices, including biomaterials, are harmonized at the international level based on the risk assessment (Amato and Ezzell, 2014; Ho et al, 2016; Pane et al, 2017; Williams, 2015). In this general context, new implantable biomaterials have to pass.
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
