How Does Medical Device Regulation Perform in the United States and the European Union? A Systematic Review

Background: Policymakers and regulators in the United States (US) and the European Union (EU) are weighing reforms to their medical device approval and post-market surveillance systems. Data may be available that identify strengths and weakness of the approaches to medical device regulation in these settings. Methods and Findings: We performed a systematic review to find empirical studies evaluating medical device regulation in the US or EU. We searched Medline using two nested categories that included medical devices and glossary terms attributable to the US Food and Drug Administration and the EU, following PRISMA guidelines for systematic reviews. We supplemented this search with a review of the US Government Accountability Office online database for reports on US Food and Drug Administration device regulation, consultations with local experts in the field, manual reference mining of selected articles, and Google searches using the same key terms used in the Medline search. We found studies of premarket evaluation and timing (n = 9), studies of device recalls (n = 8), and surveys of device manufacturers (n = 3). These studies provide evidence of quality problems in pre-market submissions in the US, provide conflicting views of device safety based largely on recall data, and relay perceptions of some industry leaders from self-surveys. Conclusions: Few studies have quantitatively assessed medical device regulation in either the US or EU. Existing studies of US and EU device approval and post-market evaluation performance suggest that policy reforms are necessary for both systems, including improving classification of devices in the US and promoting transparency and post-market oversight in the EU. Assessment of regulatory performance in both settings is limited by lack of data on post-approval safety outcomes. Changes to these device approval and post-marketing systems must be accompanied by ongoing research to ensure that there is better assessment of what works in either setting

Scouting For Approval: Lessons on Medical Device Regulation in an Era of Crowdfunding from Scanadu’s “Scout”

This Article will argue that medical device companies should be able to utilize crowdfunding to raise the necessary capital to develop a product. However, because of the risks medical devices pose, any solution that allows medical device companies to employ crowdfunding should ensure the continuing commitment to consumer safety that is at the core of FDA regulation. This Article uses the Scanadu Scout as an example and a staring point for evaluating the use of crowdfunding in the medical device industry. This Article explains how and why Scanadu broke the law when it moved the Scout, an “adulterated or misbranded” medical device, through interstate commerce in violation of 21 U.S.C. § 331(a). This Note goes on to explain what this means for other medical device companies looking to copy Scanadu’s strategy

The regulation, assessment, and management of medical devices in Mexico: How do they shape the quality of delivered healthcare?

Background: Policies for health technologies such as medical devices are essential and contribute to improved quality of healthcare. The regulation, assessment, and management represent important functions of medical devices. Insufficiently developed interactions between these functions impact the quality of delivered healthcare. To date studies lack to analyse these functions in a broad way. The aim of this study is to analyse the regulation, assessment, and management of orthopaedic medical devices in Mexico and how they shape healthcare. Methods: This qualitative study included 42 stakeholders involved directly or indirectly in the regulation, assessment, or management for orthopaedic medical devices in Mexico. Results: The fragmentation of responsibilities for medical device functions may be a central aspect of our findings concerning challenges reported by interviewees. Strengthening technovigilance based on improved reporting across health care institutions emerged as pathway to improve medical device regulation. With regard to improving the medical device assessment, a comprehensive update of the standard list represents a relevant opportunity. Integrating advanced quality attributes into procurement processes regarding decision-making, purchasing strategy, and procurement agent is needed to fostering the management. Conclusions: This study provides a broad analysis of medical device functions within a health system and highlights in this specific context how improvements might be achieved. It addresses a broad range of interest groups represented by policy makers, health service providers, managers and administrators of healthcare facilities, and doctors with an interest in health technologies. In this paper we highlight important themes that influence outputs and outcomes of the regulation, assessment, and management and discuss strategies in fostering these areas. To date, the regulation, assessment, and management of medical devices are rarely analysed in a broad way, even though these functions importantly contribute to the successful implementation of health technology policies. The quality of delivered healthcare is influenced by the performance between and within these functions. In Mexico, little discussion has been raised on challenges of the regulation, assessment, and management of medical devices. Changes to current processes and practices can improve outputs and outcomes of these functions and positively influence the quality of delivered healthcare. Stakeholder involvement and commitment is essential to this

Relationship Between EU Membership & UK Medical Device Innovation

Thirty-eight million people contact a medical device every day in the UK. The UK has over 3000 companies employing 76 000 people in medical technology. Currently valued at £17 billion and growing at rates exceeding 6%, the UK has remained a leader in medical device innovation. Governed under the European Union (EU) Medical Device legislations, it is demonstrated that this model, and the UK's continued membership accounts to an optimal balance between safety and risk with early access to new innovation. Leaving the EU would have a detrimental effect on UK businesses where EU legislation is used for market access. With the cost of regulation increasing, and the cost of products being forced to decrease, many UK businesses will no longer find it viable to innovate and manufacture within the UK

3D bioprinting regulations: a UK/EU perspective

This section introduces the challenges 3D bioprinting poses to the existing legal regime across bioethics, safety, regenerative medicine, and tissue engineering. We briefly review the 3D bioprinting technology and look into the relevant regulatory instruments for the pre-printing, printing, and post-printing stages. Special attention is paid to the applications of the EU Advanced Therapy Medicinal Products (ATMP) Regulation and the new Medical Device Regulation (MDR)

Cardiac Catheter Reuse in An Era of Reform: Cost-Efficiency and Regulatory Policy in the Face of Scientific Uncertainty

Cardiac catheters have become an essential element of current cardiovascular practice with several hundred thousand used each year in both diagnostic and angioplasty procedures. Uke many other disposable devices they are also increasingly being reused as hospitals attempt to cut costs.' The general progression of device reuse seems to follow rather directly the rise in the expense of medical equipment and procedures. For example, in 1976, only 14% of United States' hospitals reported reusing single-use devices, while in 1982, 90% of hospitals admitted practicing reuse.2 As for the government's regulation of such reuse, 1981 saw the FDA issuing guidelines practically proscribing the reuse of catheters when their average cost was only $10-$25.~ Even as late as 1987, however, only 2.4 full-time FDA employees and $19,000 were dedicated to monitoring the reuse of nondurable devices.4 The General Accounting Office concluded that the FDA knew of less than 1% of medical device problems occurring in hospitals.5 On the heels of the longstanding debate about the reuse of hemodialyzers and the Safe Medical Devices Act of 1990 and 1992 Medical Device Amendments, it appears as if the FDA is more receptive to tightening regulatory control over medical device reuse

AN INDECIPHERABLE DEBATE? AN OVERVIEW OF OPPOSING PERSPECTIVES AND THE SEARCH FOR A COHERENT REGULATORY SCHEME FOR THE REPROCESSING AND REUSE OF SINGLE-USE MEDICAL DEVICES

Caught in the middle of this controversy, the FDA has struggled for only the past few years to devise a conclusive regulatory strategy for medical device reuse. Many critics claim, however, that this action by the FDA comes too little and too late. Indeed, one angry journalist has said of the FDA: "Acting more like a lookout than a law enforcer, the Food and Drug Administration has spent the past 22 years standing aside as hundreds - perhaps thousands - of hospitals have begun reusing disposable medical devices, even though such devices have been bathed in blood, and even though the instruments carry warnings against the practice." Not wishing to rush to judgment like these and other impassioned consumer groups, though, the FDA has chosen to proceed cautiously thus far, seeking first to discern and articulate the many discordant views in this debate before formulating a final guidance rule. This paper will explore, in turn, the many different perspectives inherent in the dispute over medical device reuse: the patient and consumer perspective; the health care provider perspective; the device manufacturer perspective; and also, the perspective of a new industry player, the third-party medical device reprocessor. It will then proceed to review the brief history of FDA regulation of medical device reuse from its outset to the current day. Finally, it will conclude with recommendations for additional measures the FDA ought to consider in arriving at an ultimate regulatory scheme

Regulating Cochlear Implants: The Legal Response to a Scientific and Cultural Revolution

This paper is a case study on the cochlear implant device. The inquiry will explore the important aspects of the device's intended use, its legal regulation, and its moral impact. Through this case study I hope to illustrate how this particular technology distinguishes itself from other medical devices that the Food and Drug Administration regulates. I also examine how well the FDA answers the unique scientific and ethical questions that the device poses. This paper looks at the legal response to cochlear implants through the lense of the implant's societal impact. The research for this paper proceeded in four parts. The first part consisted of reading industry articles, reviews, and manifests in order to understand the hard science of the device. The next part was to understand the regulatory scheme. For that I consulted my Food and Drug law casebook, law review articles that dealt with medical device regulation, and noted cases on the matter. I then tried to ascertain the legal issues that were most pressing to the people who worked directly with the technology. I did this mainly through interviews of clinicians, manufactures, educators, and patients. Finally I consulted books and articles written by or about the leading detractors of the technology, focusing those who oppose it on moral and ethical grounds. This then required me to look towards common law (particularly the field of Family Law) to determine if these detractors had cognizable legal claims

Religion and Medicine: Why does religion play a role in medical regulation?

A comparison of the treatment of FDA regulation of religious devices with other intersections between general regulatory schemes and religious freedom. Comparisons included: religious fraud laws, regulation of faith healers under medical practitioner laws, and regulation of Native American religious sites on federal land. Also compared the treatment of the Church of Scientology in three other countries: the United Kingdom, Australia, and Germany with the Church’s treatment in the United States. The paper finds that the current approach to federal regulation of medical devices is probably the best way in which to regulate them, with the possible exception of the problems associated with defining religion and religious materials. The paper also finds that the treatment of religions with respect to general regulations is not preferable to the system of medical device regulation existent in the United States

"Regulating Healthcare Technologies and Medical Supplies: A Comparative Overview"

A complex relationship exists among EU regulations, current national practices and rules, institutional capacities to implement regulatory adjustments and the legacy of past health and regulatory policy and traditions. However, there is little empirical information on medical devices policy, the medical devices industry, and the assurance of medical device safety and usage. Drawing on a review of the secondary literature and on-going field work, the evidence suggests that the current mix of statecentric and self-regulatory traditions will be as important in determining the implementation and final outcomes of EU-rules as the new rules themselves. EU directives redesign rules, but they do not necessarily lead to institutional change, create institutional capacities, or alter old practices in the short term. Neither EU directives nor national regulatory adjustments determine the "man-machine/skill-experience" interface which is shaped and influenced by local medical traditions and the acceptance of these traditions by local publics