European Class III Medical Devices: Strategic Considerations for Marketing in the Middle East

2019 ◽  
pp. 119-127
Author(s):  
Rami Al-Khateeb
Keyword(s):  
Middle East ◽  
Medical Devices ◽  
Class Iii

scholarly journals RW3 The Use of Real-World Evidence in HTA of CLASS III Medical Devices in Europe

2020 ◽  
Vol 23 ◽  
pp. S758
Author(s):  
P. Klein ◽  
S. de Groot ◽  
H.M. Blommestein ◽  
B. Pongiglione ◽  
A. Torbica ◽  
...  
Keyword(s):  
Medical Devices ◽  
Real World ◽  
Class Iii ◽  
Real World Evidence

scholarly journals Evaluating Medical Devices Remotely: Current Methods and Potential Innovations

2020 ◽  
Vol 62 (7) ◽  
pp. 1041-1060
Author(s):  
Anne Collins McLaughlin ◽  
Patricia R. DeLucia ◽  
Frank A. Drews ◽  
Monifa Vaughn-Cooke ◽  
Anil Kumar ◽  
...  
Keyword(s):  
Data Collection ◽  
Medical Device ◽  
Medical Devices ◽  
Class Iii ◽  
Participant Recruitment ◽  
Medical Device Design ◽  
Remote Testing ◽  
Behavioral Studies ◽  
3D Printed ◽  
Remote Evaluation

Objective We present examples of laboratory and remote studies, with a focus on studies appropriate for medical device design and evaluation. From this review and description of extant options for remote testing, we provide methods and tools to achieve research goals remotely. Background The FDA mandates human factors evaluation of medical devices. Studies show similarities and differences in results collected in laboratories compared to data collected remotely in non-laboratory settings. Remote studies show promise, though many of these are behavioral studies related to cognitive or experimental psychology. Remote usability studies are rare but increasing, as technologies allow for synchronous and asynchronous data collection. Method We reviewed methods of remote evaluation of medical devices, from testing labels and instruction to usability testing and simulated use. Each method was coded for the attributes (e.g., supported media) that need consideration in usability studies. Results We present examples of how published usability studies of medical devices could be moved to remote data collection. We also present novel systems for creating such tests, such as the use of 3D printed or virtual prototypes. Finally, we advise on targeted participant recruitment. Conclusion Remote testing will bring opportunities and challenges to the field of medical device testing. Current methods are adequate for most purposes, excepting the validation of Class III devices. Application The tools we provide enable the remote evaluation of medical devices. Evaluations have specific research goals, and our framework of attributes helps to select or combine tools for valid testing of medical devices.

scholarly journals Clinical Trial Assessment Principles of National Class III Medical Devices in China

2019 ◽  
Vol 11 (5) ◽  
pp. 715-719
Author(s):  
Yue Min ◽  
Jin‐tao Gao ◽  
Jing Wu ◽  
Bao Zhai ◽  
Dan Han ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Medical Devices ◽  
Class Iii

Regulatory Assessment of Premarket Approval of Medical Devices in US and EU

2017 ◽  
Vol 9 (04) ◽  
Author(s):  
M.P. Venkatesh ◽  
Divya Bandla
Keyword(s):  
United States ◽  
European Union ◽  
Medical Devices ◽  
The United States ◽  
The European Union ◽  
Class Iii ◽  
Risk Class ◽  
Class Iib ◽  
Set Up ◽  
Premarket Approval

The demand for medical devices globally has raised the attention of government regulatory bodies to ensure the safety and effectiveness of these products. Developed markets, such as the United States and European Union, have set up wellestablished regulatory systems for medical devices, which have consistently been amended to accommodate the changing requirements of safety and the trend of globalization. The way in which devices are regulated in the European Union is very different from that of United States, especially in terms of the clinical data required for premarket approval. This has introduced significant differences in time-to-market approval for both United States and European Union, particularly in the case of high-risk Class III and Class IIb implantable devices. Systems for approving new medical devices must provide pathways to market important innovations besides ensuring that patients are adequately protected. To achieve these goals, the United States and the European Union use a combination of premarket testing and postmarket vigilance but with some marked contrasts in their approaches. Features of both environments require reform, as well as continuing research to assess policy changes which will benefit device manufacturers to develop devices which can be marketed both in US and EU simultaneously

Regulation of Medical Devices and their Clinical Trials Studies in the USA: An Update

2020 ◽  
Vol 13 (2) ◽  
pp. 94-109
Author(s):  
Manita ◽  
Aakash Deep ◽  
Vikram ◽  
A.C. Rana ◽  
Monu Yadav ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Medical Device ◽  
Medical Devices ◽  
Clinical Studies ◽  
Healthcare Sector ◽  
Regulatory Body ◽  
Class Iii ◽  
General Control ◽  
Dental Floss ◽  
The Usa

Background: Need for Medical devices is very important in the healthcare sector and related processes for global regulation. Medical devices are the apparatus or instruments which are specifically used for diagnostics and therapeutic applications. In the USA, a regulatory body known as FDA (Food and Drug Administration) has its unit called CDRH which looks the manufacture, packaging and use of medical devices in the USA. Objective: In USA, Medical devices are classified into 3 classes: class I which look for the medical devices used for the general control as dental floss and bandages, etc., class II which regulate the medical devices used for the general control as well as special control as powered wheelchairs and pregnancy kits. Class III medical devices look the general control. PMA (Premarket Approval) and Premarket Notification application has been filed to FDA for seeking the market authorization of medical devices. We perform clinical trials for medical device which are quite different from the clinical trials performed for drug analysis. These trials are performed on various age groups such as on paediatrics, adult and old age group commonly called phase 1,2,3,4. Regulatory approval of high-risk medical device is based on clinical studies submitted with pre-market approval. The main objective of this article is to make the researcher aware of the regulation and clinical trials of medical devices in the USA. Conclusion: Every medical device should comply with FDA, QMS and QSR for marketing in the USA. The present article has focused on the regulation of medical devices, clinical trial phases and clinical studies on medical devices.

scholarly journals Comparative Study of Pre-Market Approval Process and Denovo Process for Medical Devices

2013 ◽  
Vol 11 (01) ◽  
pp. 74-82
Author(s):  
Akash Dambal ◽  
Harrison Michael Zaphrey ◽  
M. P. Venkatesh ◽  
Kaushik Devaraju ◽  
T. M. Pramod Kumar
Keyword(s):  
High Risk ◽  
Medical Devices ◽  
De Novo ◽  
The United States ◽  
Class I ◽  
Class Iii ◽  
Moderate Risk ◽  
Risk Class ◽  
Market Approval ◽  
Novel Devices

FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. Regulatory control increases from Class I to Class III. Most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Pre-market Notification 510(k); and most Class III devices require Pre-market Approval.The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the De Novo classification option as an alternate pathway to classify novel medical devices that had automatically been placed in Class III after receiving a “not substantially equivalent” determination in response to a pre-market notification [510(k)] submission.Class III Devices are those considered as high risk along these lines requiring the regularly lengthier Pre-market Approval (PMA) process. The new De Novo process was designed to usher through any new device that was both Unprecedented (novel) and Low to moderate risk (or with a risk that was easily mitigated). The most inventive gadgets are considered high-hazard due to the non-attendance of equivalent items and follow either the De Novo or PMA path. Truly high-risk devices, in which deficient data exists to decide if general and special controls are sufficient to give sensible attestation of the item’s safety and effectiveness, follow the PMA pathway. Novel devices that do not have a predicate are classified in the highest risk class,despite the level of genuine risk it postures or the capacity of general and special controls to guarantee safety and effectiveness. The De Novo process allows these novel devices with low to moderate risk to be reclassified from a high-risk class, which requires a PMA.

U.S. FDA Perspective on the Regulation of Cyanoacrylate Polymer Tissue Adhesives in Clinical Applications

2007 ◽  
Vol 539-543 ◽  
pp. 692-697 ◽  
Author(s):  
George J. Mattamal
Keyword(s):  
Medical Devices ◽  
Class Ii ◽  
Clinical Applications ◽  
Class I ◽  
Tissue Adhesive ◽  
Embolic Agent ◽  
Guidance Document ◽  
Class Iii ◽  
Tissue Adhesives ◽  
Orthodontic Bracket

A brief description of the uses and clinical applications of synthetic cyanoacrylate polymer adhesive/glues that have been cleared and/or approved as medical devices by FDA since the Medical Device Amendments of 1976 were enacted. This includes cyanoacrylate Class I devices (Exempt and not Exempt devices), Class II cyanoacrylate devices such as Dental Cements and Orthodontic Bracket Adhesives, and Class III (PMA) devices such as Dermabond™, Indermil™ Tissue Adhesive, and Trufill® n-Butyl Cyanoacrylate Embolic Agent. By citing an example of recently FDA approved Class III (PMA) devices in the Cyanoacrylate technology, the author provides a brief discussion of the FDA approval process of medical devices. It includes the FDA issues regarding the published guidance document for "Cyanoacrylate Topical Tissue Adhesives" that will provide guidance to regulatory personnel and manufacturers in the preparation of IDE applications and in the development of valid scientific evidence to support PMA applications for cyanocrylate tissue adhesives intended for topical approximation of skin and others. Also, the author provides a short regulatory description of US FDA; under what laws its operates, how FDA evaluates new devices for marketing, and how the device regulatory system works, for example, Class I, Class II, and Class III cyanoacrylate medical devices.

MEDICAL DEVICE RECALLS IN CANADA FROM 2005 TO 2015

2017 ◽  
Vol 33 (6) ◽  
pp. 708-714
Author(s):  
Anna R. Gagliardi ◽  
Julie Takata ◽  
Ariel Ducey ◽  
Pascale Lehoux ◽  
Sue Ross ◽  
...  
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Class Ii ◽  
Type I ◽  
Intermediate Risk ◽  
Class Iii ◽  
Potential Harm ◽  
Risk Class ◽  
New Class ◽  
Health Canada

Objectives: Medical devices are ubiquitous in modern medical care. However, little is known about the epidemiology of medical devices in the healthcare marketplace, including the rate at which medical devices are subject to recalls or other advisories. We sought to study the epidemiology of medical devices in Canada, focusing on device recalls. In Canada, a recall may signify a variety of events, ranging from relatively minor field safety notifications, to removal of a product from the marketplace.Methods: We used data from Health Canada to study medical device recalls in Canada from 2005 to 2015. We analyzed the risks of medical device recalls according to the risk class of the device (I lowest; IV highest) and the hazard priority of the recall (Type I highest potential harm; Type III lowest potential harm).Results: During a 10-year period, there were 7,226 medical device recalls. Most recalls were for intermediate risk class (Class II, 40.1 percent; Class III, 38.7 percent) medical devices. Among recalled devices, 5.0 percent were judged to have a reasonable probability of serious adverse health consequences or death (Type I recall Hazard Priority classification). While the number of medical devices marketed in Canada is not known, over a similar 10-year period, 24,849 new Class II, II, and IV medical device licenses were issued by Health Canada.Conclusions: Several hundred medical device recalls occur in Canada each year. Further research is needed to characterize the nature of medical device recalls, and to explore how consumers use information about recalls.

PP166 RedETS: 10 Years Of Economic HTA (Medical Devices) In Spain, 2006–2016

2018 ◽  
Vol 34 (S1) ◽  
pp. 131-132
Author(s):  
Emmanuel Gimenez Garcia ◽  
Mireia Espallargues ◽  
Toni Dedeu
Keyword(s):  
Medical Devices ◽  
Ad Hoc ◽  
Markov Models ◽  
Univariate Analysis ◽  
National Health System ◽  
Cost Utility ◽  
Economic Evaluations ◽  
Class Iii ◽  
Quality Checklist

Introduction:RedETS, created in 2006, is the Spanish network of health technology assessment agencies. The objective of this work is to describe and assess the quality of the full economic evaluation reports on medical devices (FEEMD) carried out by RedETS.Methods:The FEEMD were identified through the RedETS website publications database. Assessments about screening technologies were not included. The characteristics of FEEMD were analyzed using a formal RedETS HTA quality checklist. The characteristics extracted were analyzed through a descriptive univariate analysis.Results : Twenty-six FEEMD were found. The publication years were distributed quite uniformly over time (approximately 2/year), although 7 were published in 2008 and 7 in 2013. Thirteen studies analyzed cost-utility, ten cost-effectiveness but not utility, and three both. The most frequent medical devices (MD) class analyzed were “In vitro diagnosis MD” (n = 8) and Class III products (8). The most frequent sources to analyze effectiveness were literature (22) and data collected through ad hoc studies (6). The main sources of unit costs were official public tariffs (14), manufacturers direct values (10) analytical accounting of one/more centers or regions (11) and DRGs (7). In relation to the modelling used, 14 evaluations performed Markov models and 7 decision trees. The perspective of 23 studies was that of the National Health System (NHS), and the rest corresponded to the perspective of a specific region (2) or social perspective (1). All studies analyzing time horizons greater than 1.5 years, except for 1, applied discount rates in the modelling. All studies included a sensitivity analysis.Conclusions:The economic evaluations of MD published by the RedETS accomplish most of the quality checklist aspects and are therefore exhaustive. These FEEMD have been used in the framework of decision making for an efficient management of the NHS basic portfolio.

scholarly journals Changes to the International Regulatory Environment

2012 ◽  
Vol 6 (2) ◽  
Author(s):  
Martin McHugh ◽  
Fergal McCaffery ◽  
Valentine Casey
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
The United States ◽  
Development Project ◽  
Regulatory Approval ◽  
Data Systems ◽  
The European Union ◽  
Class Iii ◽  
Rule Changes ◽  
Final Rule

Since 2010, two significant international regulations regarding medical device development have come into force, the amendment to the European Union (EU) Medical Device Directive (MDD) 2007/47/EC and the United States (US) Food and Drug Administration (FDA) final rule on Medical Device Data Systems (MDDS). Adherence to these regulations is mandatory to be able to market a medical device in the respective region. The ability to understand these regulations and apply them to a development project can be difficult. The MDDS final rule changes the safety classification of a number of devices from Class III-high risk to Class I-low risk. The aim of this regulation is to make the process of achieving regulatory approval for manufacturers easier. The MDD aims to provide guidance for the development of medical devices to be marketed for use within the EU. It also provides defined pathways which manufacturers can follow in order to achieve regulatory approval. However, changes made as part of an amendment to the directive have a direct impact on the development of medical devices. One of the most significant changes as part of this amendment is for software to be potentially considered as a medical device in its own right and potentially the only element in a medical device subject to regulatory conformance. These regulations have created confusion surrounding specific areas, such as the use of mobile device applications for healthcare purposes. This article describes the key points of these latest regulatory changes that medical device manufacturers need to be aware of.

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