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High profile device failures have highlighted the inadequacies of current regulation. Art Sedrakyan and colleagues call for a move to a graduated model of approval and suggest a framework to achieve this goal

As compared with Europe, the United States generally requires more rigorous clinical testing of high-risk devices, which delays patients' access to new devices but may provide better assurance of device safety. Millions of patients worldwide depend on an ever-widening array of medical devices for the diagnosis and management of disease. In the United States, the Food and Drug Administration (FDA) requires manufacturers of high-risk devices such as heart valves and intraocular lens implants to demonstrate safety and effectiveness before the devices can be marketed. However, some policymakers and device manufacturers have characterized U.S. device regulation as slow, risk-averse, and expensive. 1 , 2 Other experts, such as those at the Institute of Medicine, have suggested that current premarketing procedures may not be comprehensive enough and may be particularly dangerous for devices that have . . .

In recent months, the FDA has declined to permit use of eight new sunscreen ingredients (that are already in use in Europe) without additional data. The controversy says as much about how the agency works as it does about sunscreen regulation. In May 2015, the 21st Century Cures Act was introduced in the U.S. House of Representatives, with the goal of promoting the development and speeding the approval of new drugs and devices. 1 Championed by the pharmaceutical, biotechnology, and device industries, the bill was approved unanimously (51 to 0) in committee and continues to be debated. If enacted into law, some of its provisions could have a profound effect on what is known about the safety and efficacy of medical products, as well as which ones become available for use. Some aspects of the bill could indeed enhance the development of . . .

This article calls attention to an open public comment period regarding a proposed new rule from the Department of Health and Human Services that affects clinical trial registration and results reporting. Broad access to information about clinical trials and their findings is critical for advancing medicine, promoting public health, and fulfilling ethical obligations to human volunteers. 1 Traditional methods of information dissemination (e.g., presentations and publication) may nevertheless leave distortions and gaps in the knowledge base because the results of many trials are not published. 2 – 4 Title VIII of the Food and Drug Administration (FDA) Amendments Act of 2007 (FDAAA) 5 addressed some of these concerns by requiring the registration and submission of summary results information to ClinicalTrials.gov for certain clinical trials of drugs (including biologic products) and devices. The Department of Health . . .

Regulation and postmarket surveillance of medical devices have been criticized for being too lenient as compared to drug regulation and postmarket surveillance. Little is known about the factors that determine which medical devices are chosen for implementation among similar medical devices. Our aim was to systematically identify and characterize empirical studies on medical device regulation, implementation and postmarket surveillance, and to describe the recurring themes and trends in the studies. The scoping review was preregistered, with the protocol publicly available (https://osf.io/mx36f). We followed the JBI guidelines for scoping reviews and reported the review in accordance with PRISMA-ScR guidelines. Last searches were done in MEDLINE and Embase through Ovid on 8th of February 2024. We included primary studies with empirical data, and we excluded any secondary studies such as editorials, opinion papers or systematic reviews using bibliographic databases as the primary data source. We were interested in studies that examined medical devices approved by the U.S. Food and Drug administration (FDA) and European Union (EU), and any studies on the decision-making process regarding medical device implementation. We described study characteristics and mapped them graphically. Recurring themes were presented in a table. Furthermore, we reported conclusions from identified essential studies and provided a summary of the main results. Graphs and descriptive statistics were done in R version 4.3.2, package ggplot2. We screened 3862 titles/abstracts, after which 368 records were assessed in full-text, yielding 139 studies included in the review. Out of these, 68 studies (49%) examined approval, 40 studies (29%) examined postmarket surveillance, 17 studies (12%) implementation and 14 studies (10%) both approval and postmarket surveillance. The studies were published between 2003-2024 and consisted of 77 cross-sectional studies (55%), 35 cohort studies (25%), 20 qualitative studies (14%) and seven mixed-methods studies (5%). As data source, 90 studies (65%) used FDA, 25 studies (18%) other data sources and 24 studies (17%) interviewees through semi-structured interviews. Nine out of the 139 studies investigated regulatory approval within the EU. Predominantly, the studies reported that the available clinical evidence for medical device approval was considered inadequate, making it difficult for stakeholders to evaluate the suitability of a medical device for implementation. Studies on medical devices are mainly conducted using FDA device databases, since restricted access to publicly available data has hindered research within the EU. Research on how and why specific medical devices are chosen and adopted into clinical practice is limited. We suggest that evidence on medical device efficacy and harms should be strengthened through higher demands from regulatory agencies and improvement of accessible registries.

CMS recently finalized a rule that could substantially alter Medicare-coverage decisions for certain new medical devices. The rule is intended to expedite coverage, but it would undermine Medicare’s authority to consider the clinical evidence supporting device adoption.

The technology could revolutionize efforts to immunize against HIV, malaria, influenza and more. The technology could revolutionize efforts to immunize against HIV, malaria, influenza and more.

The FDA has granted marketing authorization for a high-throughput genomic sequencer, Illumina's MiSeqDx, which will allow the development of innumerable new genome-based tests. Access to genomic data may transform research, clinical care, and patient engagement. This year marks 60 years since James Watson and Francis Crick described the structure of DNA and 10 years since the complete sequencing of the human genome. Fittingly, today the Food and Drug Administration (FDA) has granted marketing authorization for the first high-throughput (next-generation) genomic sequencer, Illumina's MiSeqDx, which will allow the development and use of innumerable new genome-based tests. When a global team of researchers sequenced that first human genome, it took more than a decade and cost hundreds of millions of dollars. Today, because of federal and private investment, sequencing technologies have advanced dramatically, and a human genome . . .

Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.