Postmarket surveillance approaches for biomaterials and medical devices in the USA

Author(s):  
K. Desai
Keyword(s):  
2019 ◽  
Vol 5 (1) ◽  
pp. 605-608
Author(s):  
Marcel Vila Wagner ◽  
Thomas Schanze

AbstractImportant achievements such as the discovery of penicillin increased life expectancy in the 19th century. At the beginning of the 20th century, the influence of technical equipment and biomedical research led to a further leap in life expectancy. The use of computer devices with sophisticated software also improved the quality of life. This is linked to the fact that all these achievements have now led to the emergence of one of the largest import and export markets in the USA, alongside the european union (EU), which is an association of European states. In order to guarantee a uniform quality of this abundance of different products and therapies, there are worldwide corresponding regulations, to which all manufacturers must adhere. The entry into force of these regulations, with the associated approval and testing obligations for each individual medical device, ensures that a consistently high quality of products is used on patients. Of course, high quality as well as high functionality and safety levels of medical products are a must. However, the implementation of these regulations is realized differently in the various markets, as there is no global harmonization. This work focuses on approval procedures for medical devices in Europe (EU) and the USA and compares significant differences in the approval procedures, which are shown as a graphical comparison. An example is an approval of medical devices by the U.S. Food and Drug Administration (FDA), which is an US government agency. In Europe (EU) there is a manufacturer’s declaration of conformity for the approval.


Author(s):  
Manita ◽  
Aakash Deep ◽  
Vikram ◽  
A.C. Rana ◽  
Monu Yadav ◽  
...  

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.


2021 ◽  
pp. medethics-2020-107031
Author(s):  
Daniel B. Kramer ◽  
Efthimios Parasidis

Many high-risk medical devices earn US marketing approval based on limited premarket clinical evaluation that leaves important questions unanswered. Rigorous postmarket surveillance includes registries that actively collect and maintain information defined by individual patient exposures to particular devices. Several prominent registries for cardiovascular devices require enrolment as a condition of reimbursement for the implant procedure, without informed consent. In this article, we focus on whether these registries, separate from their legal requirements, have an ethical obligation to obtain informed consent from enrolees, what is lost in not doing so, and the ways in which seeking and obtaining consent might strengthen postmarket surveillance in the USA.


2018 ◽  
Vol 2 (4) ◽  
pp. 33-41 ◽  
Author(s):  
Vaidehi Limaye ◽  
Gerhard Fortwengel ◽  
Dnyanesh Limaye

Nanotechnology is emerging as one of the key technologies of the 21st century and is expected to enable developments across a wide range of sectors that can benefit citizens. Nanomedicine is an application of nanotechnology in the areas of healthcare, disease diagnosis, treatment and prevention of disease. Nanomedicines pose problem of nanotoxicity related to factors like size, shape, specific surface area, surface morphology, and crystallinity. Currently, nanomedicines are regulated as medicinal products or as medical devices and there is no specific regulatory framework for nanotechnology-based products neither in the EU nor in the USA. This review presents a scheme for classification and regulatory approval process for nanotechnology based medicines.


2021 ◽  
Vol 8 (2) ◽  
pp. 22-34
Author(s):  
Tuğşad Tülbentçi ◽  
◽  
Enis Faik Arcan ◽  

The reason behind this article is the idea that “Expandable Hospital Competitions” are significant architectural events due to their organization in two different countries. Additionally, the research topic becomes much important due to the differences in “Hospital Design Standards” arising from the lapse of time as almost half a century since such competitions are organized at different times. The first competition, called “Expandable Hospital,” is organized in Turkey in the year 1975, while the second competition is named “Small Hospital-Big Idea,” which was organized in the USA in the year 2011. Due to such a year gap, the research becomes more multi-dimensional, with significant differences in the competition space programs. At the same time, there have been some improvements socially, general health conditions due to the changes in welfare and communication conditions, etc., hospital organization, medical practices, pharmaceutical manufacturing, medical devices, and medical equipment. All of such factors have changed the space standards that affect the hospital organization in the long year gap. Based on such developments, this study aims to identify the differences between hospital competitions and space programs under the existing conditions through the performance of comparison


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