Improving Medical Device Regulation: The United States and Europe in Perspective

Published on Mar 1, 2014in Milbank Quarterly7.425
· DOI :10.1111/1468-0009.12043
Corinna Sorenson14
Estimated H-index: 14
(LSE: London School of Economics and Political Science),
Michael Drummond73
Estimated H-index: 73
(Ebor: University of York)
Context: Recent debates and events have brought into question the effectiveness of existing regulatory frameworks for medical devices in the United States andEuropetoensuretheirperformance,safety,andquality.Thisarticleprovides a comparative analysis of medical device regulation in the two jurisdictions, explores current reforms to improve the existing systems, and discusses additional actions that should be considered to fully meet this aim. Medical device regulation must be improved to safeguard public health and ensure that high-quality and effective technologies reach patients. Methods: We explored and analyzed medical device regulatory systems in the United States and Europe in accordance with the available gray and peerreviewed literature and legislative documents. Findings: The two regulatory systems differ in their mandate and orientation, organization, pre- and postmarket evidence requirements, and transparency of process. Despite these differences, both jurisdictions face similar challenges for ensuring that only safe and effective devices reach the market, monitoring realworlduse,andexchangingpertinentinformationondeviceswithkeyuserssuch as clinicians and patients. To address these issues, reforms have recently been introduced or debated in the United States and Europe that are principally focused on strengthening regulatory processes, enhancing postmarket regulation through more robust surveillance systems, and improving the traceability and monitoring of devices. Some changes in premarket requirements for devices are being considered. Conclusions: Although the current reforms address some of the outstanding challenges in device regulation, additional steps are needed to improve existing policy. We examine a number of actions to be considered, such as requiring
  • References (23)
  • Citations (77)
📖 Papers frequently viewed together
171 Citations
74 Citations
75 Citations
78% of Scinapse members use related papers. After signing in, all features are FREE.
Proposals for regulating medical devices, which the European parliament will vote on next month, are proving controversial. Deborah Cohen investigates the arguments
12 CitationsSource
#1Brent M. Ardaugh (BU: Boston University)H-Index: 2
#2Stephen E. GravesH-Index: 43
Last. Rita F. RedbergH-Index: 59
view all 3 authors...
Medical device makers have been able to obtain FDA clearance by claiming substantial equivalence to earlier devices (or parts thereof) that may have been cleared the same way. The ancestry of a problematic metal-on-metal hip implant includes 95 different devices.
69 CitationsSource
#1Connie Chen (Stanford University)H-Index: 10
#2Sanket S. DhruvaH-Index: 19
Last. Rita F. RedbergH-Index: 59
view all 3 authors...
24 CitationsSource
#1Saptarshi Basu (FDA: Food and Drug Administration)H-Index: 1
#2John C. Hassenplug (FDA: Food and Drug Administration)H-Index: 1
The U.S. process for approving innovative, high-risk medical devices has been criticized for taking longer than the European process. But a review of the data suggests that it takes the same amount of time or less for U.S. patients to gain access to such devices.
43 CitationsSource
#1Hans Van BrabandtH-Index: 12
#2Mattias NeytH-Index: 18
Last. Frank HulstaertH-Index: 23
view all 3 authors...
Many of the 40 000 transcatheter procedures so far carried out cannot be justified on medical or cost effectiveness grounds. Hans Van Brabandt , Mattias Neyt , and Frank Hulstaert examine why practice has gone beyond the evidence
62 CitationsSource
#1Giovanna Sarno (Uppsala University)H-Index: 29
#2Bo Lagerqvist (Uppsala University)H-Index: 51
Last. Stefan James (Uppsala University)H-Index: 74
view all 9 authors...
To compare the long-term outcome after percutaneous coronary intervention with onew-generation' drug-eluting stents (n-DES) to oolder generation' DES (o-DES), and bare-metal stents (BMS) in a real- ...
258 CitationsSource
#1Daniel B. Kramer (BIDMC: Beth Israel Deaconess Medical Center)H-Index: 27
#2Shuai Xu (Harvard University)H-Index: 16
Last. Aaron S. Kesselheim (Harvard University)H-Index: 44
view all 3 authors...
171 CitationsSource
Urgent review of the regulation and postmarketing evidence requirements is needed Complete and utter confusion now reigns over Poly Implant Prosthese (PIP) breast implants and what to do, particularly with regard to the evidence needed for their regulation, effectiveness, and, more importantly, safety. Confusion between the European and the American regulatory systems is not helping, and the situation needs radical reform. The French government has advised 30 000 women to have their implants rem...
22 CitationsSource
#1Diana M. ZuckermanH-Index: 9
#2Paul BrownH-Index: 4
Last. Steven E. NissenH-Index: 90
view all 3 authors...
139 CitationsSource
#1Alan G. Fraser (Cardiff University)H-Index: 26
#2Mitchell W. Krucoff (Duke University)H-Index: 63
Last. Sidney C. Smith Mdfacc (UNC: University of North Carolina at Chapel Hill)H-Index: 145
view all 5 authors...
No implantable medical device is perfectly safe. It is the duty of manufacturers and regulators to minimise risks—and the purpose of evaluating and regulating devices is to ensure safety and effectiveness. The product life cycle of many medical devices is short—often quoted as an average of two years or less—because of the rapid rate of technological change and because of frequent modifications (called iterative changes) to their design, manufacture, or programming. It would be desirable for all...
20 CitationsSource
Cited By77
#1Patricia Ex (Technical University of Berlin)H-Index: 1
#2Verena Vogt (Technical University of Berlin)H-Index: 6
Last. Cornelia Henschke (Technical University of Berlin)H-Index: 8
view all 4 authors...
: Most hospital payment systems based on diagnosis-related groups (DRGs) provide payments for newly approved technologies. In Germany, they are negotiated between individual hospitals and health insurances. The aim of our study is to assess the functioning of temporary reimbursement mechanisms. We used multilevel logistic regression to examine factors at the hospital and state levels that are associated with agreeing innovation payments. Dependent variable was whether or not a hospital had succe...
1 CitationsSource
The growing number of emerging medical technologies and sophistication of modern medical devices (MDs) that improve both survival and quality of life indexes are often challenged by alarming cases of vigilance data cover-up and lack of sufficient pre- and post-authorization controls. Combining Quality with Risk Management processes and implementing them as early as possible in the design of MDs has proven to be an effective strategy to minimize residual risk. This article aims to discuss how the...
#1Sina Faezi (UCI: University of California, Irvine)H-Index: 6
#2Sujit Rokka Chhetri (UCI: University of California, Irvine)H-Index: 8
Last. Mohammad Abdullah Al Faruque (UCI: University of California, Irvine)H-Index: 17
view all 7 authors...
Synthetic DNA molecules play an essential role in genomics research and are a promising, high-capacity data storage medium. Currently, researchers use automated DNA synthesizers to custom-build sequences of oligonucleotides (short DNA strands) using the nucleobases: Adenine (A), Guanine (G), Cytosine (C), and Thymine (T). Research laboratories invest large amounts of capital to engineer unique oligonucleotide sequences. In our work, we demonstrate the vulnerability of commonly used DNA synthesiz...
#2Neha SamiH-Index: 5
Last. Asimul IslamH-Index: 23
view all 6 authors...
#1Marcello Ienca (ETH Zurich)H-Index: 10
#2James Scheibner (ETH Zurich)H-Index: 1
Abstract The word “neurohacking” has been increasingly used in the popular and scientific literature to denominate a variety of activities related to the development, use and misuse of neurotechnology. Given the qualitative heterogeneity of these activities, it is questionable that the notion of neurohacking is being used in a semantically unambiguous manner, hence suitable for scientific investigation. This contribution will attempt to cast light on the notion of neurohacking by conducting a sc...
#1Dinar Kale (OU: Open University)H-Index: 10
Using the Indian medical device sector as a case study, this research examines the evolution of regulatory frameworks by analysing the conditions and processes through which regulatory environments for a technology-based industry come about. It also attempts to unpack the complex relationships between industrial capabilities in healthcare technology and human health, and the role of regulation in facilitating more inclusive healthcare and development in emerging countries. In doing so, the paper...
1 CitationsSource
#1Sumit Majumder (McMaster University)H-Index: 6
#2M. Jamal Deen (McMaster University)H-Index: 30
Last. M. Jamal DeenH-Index: 7
view all 2 authors...
Over the past few decades, we have witnessed a dramatic rise in life expectancy owing to significant advances in medical science and technology, medicine as well as increased awareness about nutrition, education, and environmental and personal hygiene. Consequently, the elderly population in many countries are expected to rise rapidly in the coming years. A rapidly rising elderly demographics is expected to adversely affect the socioeconomic systems of many nations in terms of costs associated w...
25 CitationsSource
The development of biomaterials, medical device components, finished medical products, and 3-D printed and regenerative medicine products is governed by a variety of international and country-specific standards and guidelines. Of greatest importance to planning, executing, and reporting biocompatibility, safety and efficacy studies for most biomaterials and medical components or products are the International Organization for Standardization guidelines, U.S. Pharmacopeial Convention, ASTM Intern...
4 CitationsSource
#1Philippe SerranoH-Index: 1
#2Markus HartmannH-Index: 9
Last. Christine Mayer-Nicolai (Merck Serono)H-Index: 1
view all 7 authors...
: Immune checkpoint inhibitors (ICI) have demonstrated meaningful patterns of clinical efficacy across various cancers. During their development, novel regulatory strategies and clinical design approaches were explored. This metrics-based narrative review examines submission strategies and clinical evidence expectations of the US, European, and Japanese drug agencies, as well as their impact on approval and overall development times. Also discussed is the role of emerging clinical science and bi...
3 CitationsSource