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A filler composed of calcium hydroxylapatite and carboxymethylcellulose gel (CaHA/CMC) has been shown to possess biostimulatory and skin‐tightening properties that have been applied not just to the face but also to the body to boost rejuvenation. Recently, evidence and recommendations for CaHA/CMC treatment of the face have been provided, but they are still lacking in terms of body treatment. This article aims to perform a systematic review of the literature on CaHA/CMC applications on the body and provide evidence from the literature. Currently, the only FDA‐approved indication on the body is treating the hands and a recent European Union Medical Device Regulation approval has been released for decolletage treatment. The application of hyperdilutions on the neck, feet, arms, thighs, abdomen, and other body parts has been proven to provide a skin‐tightening effect. However, despite their wide use with a good safety profile in clinical practice, recent trends and guidelines of diluted and hyperdiluted CaHA/CMC have yet to be supported by randomized controlled trials. [ABSTRACT FROM AUTHOR]

Spinal implants play a vital role in healthcare delivery, and regulations are necessary to ensure their quality, approval, access, and use. In this article, we examine the current state of regulation and approval procedures for medical devices in low- and middle-income countries (LMICs), emphasizing the situation in Tanzania. We conducted a systematic literature search and interviewed a local spine implant representative to investigate the approval, availability, and access of surgical and spinal implants in LMICs, particularly in Africa. Out of the 18 included articles, six referred to African regulations, with no mention of spinal implants. Our analysis revealed that LMICs face challenges in accessing implants due to affordability, poor supply chain, and lack of expertise for their application. However, surgeons have found alternative solutions, such as using lower-cost implants from Turkish manufacturers. The Tanzania Medical Devices and Drugs Authority oversees the local regulatory and approval process for implants. Regulation and accessibility of spinal implants in LMICs, particularly in Africa, are limited and negatively impact patient care and best medical practice. Potential solutions include capacity building within and collaboration among regulatory organizations to improve regulatory processes and allocating financial resources to qualitative and quantitative implant access. [ABSTRACT FROM AUTHOR]

One in ten U.S. patients has an internally implanted medical device. Yet, lax regulation by the U.S. Food and Drug Administration (FDA) has resulted in the approval of medical devices disproportionately harming women, including Bayer Pharmaceutical's Essure, a permanent female sterilization device. Victims of Essure often suffer adverse events, including serious injuries, device malfunctions, and death. Guided by critical feminist theorizing, this case study examines 500 public docket comments written to the FDA by female patients recounting their experiences of adverse events with Essure. Reflexive thematic analysis revealed how women: (a) voiced their experiences to contest meanings of 'safety,' expressed identification with their 'E-Sisters,' and protected future women from harm; (b) identified forces of greed, deception, and gender bias as creating the conditions for harm to befall them; and (c) enacted resistance and called for a change in the status quo by the FDA and Bayer. Theoretical and practical implications for health communication researchers, medical practitioners and educators, and regulatory agencies are offered. [ABSTRACT FROM AUTHOR]

The article focuses on nonsurgical body contouring technologies, such as cryolipolysis, microfocused ultrasound (MFU), laser therapy, radiofrequency (RF) technology, and electromagnetic muscle stimulation (EMMS), highlighting their mechanisms of action, indications, and potential adverse effects. Topics include the importance of patient selection, precautions, and the emergence of energy-based vaginal rejuvenation procedures with associated concerns about safety and efficacy.

A study published in the European Heart Journal by the CORE-MD Consortium evaluated the quality and transparency of clinical evidence for high-risk cardiovascular medical devices. The study found that evidence to support clinical benefit for these devices is sparse and largely hidden. Only half of the published clinical trials supporting approval of these devices had pre-registered study protocols, and only 19% of the clinical studies underpinning certification were randomized. The lack of high-quality evidence is concerning and threatens patient safety. Regulatory changes in both the European Union and the United States have had mixed effects on the quality of evidence used for device approval. The study highlights the need for reform and the importance of prioritizing patient safety. [Extracted from the article]

Computational models are increasingly used in high-impact decision making in science, engineering, and medicine. The National Aeronautics and Space Administration (NASA) uses computational models to perform complex experiments that are otherwise prohibitively expensive or require a microgravity environment. Similarly, the Food and Drug Administration (FDA) and European Medicines Agency (EMA) have began accepting models and simulations as forms of evidence for pharmaceutical and medical device approval. It is crucial that computational models meet a standard of credibility when using them in high-stakes decision making. For this reason, institutes including NASA, the FDA, and the EMA have developed standards to promote and assess the credibility of computational models and simulations. However, due to the breadth of models these institutes assess, these credibility standards are mostly qualitative and avoid making specific recommendations. On the other hand, modeling and simulation in systems biology is a narrower domain and several standards are already in place. As systems biology models increase in complexity and influence, the development of a credibility assessment system is crucial. Here we review existing standards in systems biology, credibility standards in other science, engineering, and medical fields, and propose the development of a credibility standard for systems biology models. [ABSTRACT FROM AUTHOR]

Gastrointestinal endoscopy is largely dependent on medical devices. The European Union (EU) has recently introduced stricter rules and regulations for the approval of medical devices. This has consequences both for endoscopists and for patients. The new regulations increase the need for clinical trials and observational studies for new and current devices used in endoscopy to ensure clinical benefit and reduce patient harm. European endoscopy environments should facilitate industry-sponsored clinical trials and registry studies to meet the demand for robust data on endoscopic devices as required in the new legislation. The European Society of Gastrointestinal Endoscopy (ESGE) will play an active role in the establishment of the new system. The EU is establishing independent expert panels for device regulation in gastroenterology and hepatology, including endoscopy, that are charged with assessing the requirements for device testing. The ESGE encourages endoscopists with expertise in the technical and clinical performance of endoscopy devices to apply for expert panel membership. The ESGE has provided information for interested endoscopists on the ESGE website. Private European companies called "notified bodies" are entitled to conduct device approval for the EU. The ESGE will actively engage with these notified bodies for topics related to the new endoscopy device approval process to ensure continued access to high quality endoscopy devices for endoscopists in Europe. [ABSTRACT FROM AUTHOR]

Artificial intelligence (AI) is becoming more widespread within radiology. Capabilities that AI algorithms currently provide include detection, segmentation, classification, and quantification of pathological findings. Artificial intelligence software have created challenges for the traditional United States Food and Drug Administration (FDA) approval process for medical devices given their abilities to evolve over time with incremental data input. Currently, there are 190 FDA-approved radiology AI-based software devices, 42 of which pertain specifically to thoracic radiology. The majority of these algorithms are approved for the detection and/or analysis of pulmonary nodules, for monitoring placement of endotracheal tubes and indwelling catheters, for detection of emergent findings, and for assessment of pulmonary parenchyma; however, as technology evolves, there are many other potential applications that can be explored. For example, evaluation of non-idiopathic pulmonary fibrosis interstitial lung diseases, synthesis of imaging, clinical and/or laboratory data to yield comprehensive diagnoses, and survival or prognosis prediction of certain pathologies. With increasing physician and developer engagement, transparency and frequent communication between developers and regulatory agencies, such as the FDA, AI medical devices will be able to provide a critical supplement to patient management and ultimately enhance physicians' ability to improve patient care. [ABSTRACT FROM AUTHOR]

The world's first accelerator based epithermal neutron source for clinical boron neutron capture therapy (BNCT) was designed, developed, and commissioned between 2008 and 2010 by Sumitomo Heavy Industries in collaboration with Kyoto University at the Kyoto University Institute for Integrated Radiation and Nuclear Science. The accelerator system is cyclotron-based and accelerates a proton up to an energy of approximately 30 MeV. The proton strikes a beryllium target, which produces fast neutrons that traverse a beam shaping assembly composed of a combination of lead, iron, aluminum, and calcium fluoride to reduce the neutron energy down to the epithermal range (∼10 keV) suitable for BNCT. The system is designed to produce an epithermal neutron flux of up to 1.4 × 10 9 n · cm − 2 · s − 1 (exiting from the moderator of a 12 cm diameter collimator) with a proton current of 1 mA. In 2017, the same type of accelerator was installed at the Kansai BNCT Medical Center and in March 2020 the system received medical device approval in Japan (Sumitomo Heavy Industries, NeuCure® BNCT system). Soon after, BNCT for unresectable, locally advanced, and recurrent carcinoma of the head and neck region was approved by the Japanese government for reimbursement covered by the national health insurance system. [ABSTRACT FROM AUTHOR]

Background/purpose: The MANTA is a dedicated plug-based large-bore vascular closure device (VCD) providing safe hemostasis in most patients, but data on the clinical impact and mechanisms of MANTA related complications are limited. This study sought to determine the frequency, impact and predictors of MANTA-related access complications.Methods/materials: This patient-level meta-analysis included data from 2 medical device approval studies and 1 post-approval registry. The primary endpoint was the composite of major and minor access complications. Technical success was defined as hemostasis with MANTA closure device without need for vascular surgery or stenting.Results: Eight hundred ninety-one patients (mean age 80) underwent transcatheter aortic valve replacement (n = 814), endovascular aortic repair (n = 71), balloon aortic valvuloplasty (n = 4) or mechanical circulatory support (n = 2). Technical success was 96.4% and median time to hemostasis was 31 (interquartile range: 17-76) seconds. The primary endpoint occurred 9.1% and bailout vascular surgery or stenting was necessary in 32 patients (3.6%). Female gender (OR: 2.63, CI: 1.46-4.73, p = 0.001), left femoral access (OR: 2.18, CI: 1.17-4.06, p = 0.015) and unfavorable arteriotomy phenotype (combination of a small femoral artery diameter with a deep arteriotomy; OR 2.27: 1.26-4.10, p = 0.006) independently predicted access complications. Access complications most often consisted of vessel dissection, stenosis or occlusion and predominantly occurred in patients with an unfavorable arteriotomy phenotype.Conclusions: Large-bore arteriotomy closure with MANTA VCD provided fast and safe hemostasis with an acceptable complication rate. Refined procedure planning and risk-stratification may further improve MANTA VCD performance. [ABSTRACT FROM AUTHOR]

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Objectives: To enhance the generalizability of the evidence it reviews, the US Food and Drug Administration (FDA) has encouraged manufacturers to expand the submission of real-world evidence (RWE). The extent to which this evidence, which is generated outside of research settings, can support decision making remains unclear. We described the current use of RWE for medical devices, assessed manufacturers' challenges in generating and using it for regulatory and coverage decisions, and identified opportunities to expand its use.Methods: We conducted 27 solo and group interviews with FDA officials and representatives of device manufacturers, payers, and health technology assessment organizations. All interviews used a semistructured protocol and were transcribed to allow thematic analysis.Results: Accessing and linking real-world data sources, identifying unique devices, capturing longitudinal data, limited staff expertise, and uncertain return on investment have hampered efforts to use real-world data. Many companies in our sample were conducting research using real-world data, but none had submitted RWE as the primary evidence supporting a premarket approval. FDA guidance was helpful, but regulatory requirements remained ambiguous and examples of successful regulatory decisions based on RWE were limited. Payers mainly used RWE to supplement experimental evidence in coverage decisions, evaluated both types of evidence in similar ways, and had concerns about the rigor of RWE.Conclusions: Technical challenges may slow efforts to generate and use RWE in the near term. Additional regulatory guidance and examples, greater use of rigorous study designs and analytic methods, and continued stakeholder engagement could accelerate the use of RWE. [ABSTRACT FROM AUTHOR]

Introduction: The Malaysia Medical Device Authority (MDA) has mandated the registration of implantable medical device (IMD) via the MeDC@St online system since 2013. The study aimed to gather information on the IMD registered in Malaysia to understand its economic importance subsequently profile its manufacturers, prior approval by the medical device authorities before the revision of the ISO10993-1 published in 2018. Methods: Permission is obtained from the MDA to access the MeDC@St online system to retrieve a five-year (2013 to 2017) registration information, which is manually retrieved using a data collection form and analysed descriptively. Results: A total of 11,956 medical devices were registered by the MDA between 2013 to 2017, whereby 16.5% of it is IMDs with the highest and lowest numbers were recorded in 2015 and 2013 with 997 and 39 registrations, respectively. The majority of the registrations consisted of IMD under the MDR technical areas of MD 0200 (20.4%) and MD 0202 (28.2), MD 0204 (9.9%) and MD 0402 (11.1%). The economies associated with the Global Harmonisation Task Force (GHTF) showed apparent influence on the IMD registered in Malaysia whereby 88.5% were manufactured, 98.9% obtained prior approval and 73.6% were assessed for conformity by entities originating from the GHTF economies. Conclusion: The IMD has substantial economic importance in Malaysia looking at the continual registration of above 150 new devices annually since 2014. It is believed that the similarity of the medical device laws with the GHTF economies has encouraged the large presence of its IMD in the Malaysia. [ABSTRACT FROM AUTHOR]

The Sakigake designation system (Sakigake) has been launched to encourage the pioneered development of innovative new medical products for the effective treatment of severe illness in Japan, which allows leveraging the several advantages in prioritized consultation, rapid review, premium drug pricing and extended data‐protection period. We retrospectively analysed the Sakigake products including drugs and regenerative medical products to clarify the achievements and the future issues in this system. From April 2015 to August 2020 (the first 5‐year trial period of Sakigake), 37 products were designated, and 10 of those were approved in Japan in which 7 new active substances achieved the first‐in‐world approvals. Oncology, neurology and cardiovascular disease were the major therapeutic areas, and those 3 accounted for 75.7% of all products. Sakigake achieved some first‐in‐world approvals by the Pharmaceuticals and Medical Devices Agency/the Ministry of Health, Labor and Welfare of innovative new medical products, although in some therapeutic areas, there remains room in stimulating drug development. [ABSTRACT FROM AUTHOR]

The authors explore the growing interest in the use of repetitive transcranial magnetic stimulation (rTMS) for the treatment of major depressive disorder (MDD). Topics discussed include the studies which investigated the effectiveness of RTMS in individuals with treatment-resistant depression (TRD), the medical device approval earned by rTMS from the U.S. Food and Drug Administration (FDA), and the need to acknowledge the neurobiological and clinical complexity of MDD in its treatment.

The article offers information on the 24th Congress of the German Society of Sterile Supply (DGSV) held on October 4-5, 2021 in Fulda, Germany and only the members of the board of directors and the speakers attended in person. It discusses that Kathrin Mann gave the first talk on the topic of "Costs of reprocessing medical devices in the outpatient operating room; and gave an overview of the surgical centre and its various areas, explaining in detail the items that had to be included.

The approval of new ophthalmic medical devices and medicinal products is governed by separate processes in Europe with different requirements, classifications, and timelines involved. For pharmaceuticals, companies can go through a centralized European-level process working with the European Medicines Agency (EMA) or a decentralized procedure working with a member state competent authority to gain approval or via mutual recognition. For medical devices, companies must work with a European Union approved Notified Body as there is no equivalent to the EMA. With medicinal products, approval can be sought as a new medicinal product, generic, known substance, or as an advanced therapy. With medical devices, the classifications are based on the use and complexity of the device as well as the risk, beginning with class I (surgical instruments and some diagnostic devices), to class IIA, class IIB, and class III, which are the most invasive devices, such as pacemakers and breast implants. From May 2021, the European Union will fully implement the Medical Device Regulation, which enforces increased requirements before class IIa and above devices can be CE marked. This process for approving medical devices and pharmaceuticals in Europe is designed to ensure that new technology is thoroughly vetted before becoming commercially available. [ABSTRACT FROM AUTHOR]

With decades of advance research and recent developments in the drug and medical device regulatory approval process, patient-reported outcomes (PROs) are becoming increasingly important in clinical trials. While clinical trial analyses typically treat scores from PROs as observed variables, the potential to use latent variable models when analyzing patient responses in clinical trial data presents novel opportunities for both psychometrics and regulatory science. An accessible overview of analyses commonly used to analyze longitudinal trial data and statistical models familiar in both psychometrics and biometrics, such as growth models, multilevel models, and latent variable models, is provided to call attention to connections and common themes among these models that have found use across many research areas. Additionally, examples using empirical data from a randomized clinical trial provide concrete demonstrations of the implementation of these models. The increasing availability of high-quality, psychometrically rigorous assessment instruments in clinical trials, of which the Patient-Reported Outcomes Measurement Information System (PROMIS®) is a prominent example, provides rare possibilities for psychometrics to help improve the statistical tools used in regulatory science. [ABSTRACT FROM AUTHOR]

The FDA already subjects most medical devices to much less stringent approval requirements than drugs and biologics, and attempts to speed up rollout during the COVID crisis have been problematic. Agency decisions, including to allow antibody test marketing without emergency use authorization or review, and the back-and-forth guidance on laboratory-developed tests, have met harsh criticism and unreliable results. Though the long-term results of these decisions are unclear, the FDA's credibility, reliability, and commitment to safety are threatened by even further lessening medical device regulatory oversight during the coronavirus pandemic. The relaxed and fix-it-later approach to many of the FDA's public health emergency decisions regarding medical devices reflect the ongoing criticisms of medical device regulation in general, specifically the 510(k) process and laboratory developed test regulation, offering a point of reflection towards reform. Adaptive legislation and a risk-based and evidentiary approach to premarket and postmarket review can begin to address these issues both generally and in an emergency context. [ABSTRACT FROM AUTHOR]

Introduction: Phosphodiesterase 5 inhibitors (PDE5i) are the first-line treatment for erectile dysfunction (ED), but there is in approximately 30% of ineffective patients or contraindicated in patients taking nitrate medications. Although vacuum erection device (VED) is the second line in ED guidelines, they have long been unavailable in Japan, due to the withdrawal of their manufacturers. Objective: A new VED, Vigor 2020, has now been manufactured and received medical approval by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. It is very important to be able to sexual intercourse with VED, recommended in the ED guidelines. We conducted a retrospective observational study of patients with Vigor 2020 in clinical practice. Methods: We analyzed male patients aged 20 years or older who presented to an outpatient clinic with ED and were treated with Vigor 2020 as a second-line treatment, because PDE5i was ineffective or contraindicated. Sexual and ejaculatory function were assessed using questionnaires [Erection Hardness Score (EHS), International Index of Erectile Function (IIEF), Male Sexual Health Questionnaire for assessing ejaculatory dysfunction (MSHQ-EjD), the numerical rating scale (NRS)]. Results: There were 34 participants who could be evaluated before and after the use of Vigor 2020, with a mean age of 57.85 (27–86) years. Significant improvement in EHS and IIEF total score were observed with the use of Vigor 2020 in all participants. There was a significant improvement in MSHQ-EjD and NRS for participants who had an EHS of 3 or higher after the use of Vigor 2020. But no significant improvement in MSHQ-EjD and NRS for participants who had an EHS of 2 or lower after the use of Vigor 2020. The participants experienced no significant adverse events. Conclusions: Vigor 2020 may be one treatment tool for ED, as defined in the ED guidelines. There is not only significant improvement of erection with Vigor 2020 but also improvement of ejaculation in cases of significant erectile efficacy. Disclosure: No. [ABSTRACT FROM AUTHOR]

While we reviewed all vaccine approvals over the past 10 years, there were a limited number of vaccines endemic to the USA on which to base our study. Vaccines are a cornerstone of the strategy to address the COVID-19 pandemic. For sex, this excludes 1 essential trial examining only the cervical cancer endpoint for Gardasil 9 approval, leaving 39 essential trials supporting 17 vaccine approvals for analysis †Age subgroup data was available for 32 essential trials supporting 16 of 17 vaccine approvals ‡Race subgroup data was available for 39 essential trials supporting 17 vaccine approvals. [Extracted from the article]

Several devices have been designed and tried over the years to percutaneously close atrial septal defects (ASDs). Most of the devices were first experimented in animal models with subsequent clinical testing in human subjects. Some devices were discontinued or withdrawn from further clinical use for varied reasons and other devices received Food and Drug Administration (FDA) approval with consequent continued usage. The outcomes of both discontinued and currently used devices was presented in some detail. The results of device implantation are generally good when appropriate care and precautions are undertaken. At this time, Amplatzer Septal Occluder is most frequently utilized device for occlusion of secundum ASD around the world. [ABSTRACT FROM AUTHOR]

The scrutiny of medical devices industry as well as pharmaceutical industry for its application in health care industry on different platform is captured the 3D printing technique. 3D printing technology withstand for a very long duration only because of the approval of medical devices, 3D printed tablets and also with the advent of USFDA guideline on technical consideration. This technology is specific to devices utilizing preservative manufacturing. Many thoughts are triggered by 3D printing this technology and for successful delivery of intended product which is necessarily take into a consideration. In this review paper expectation limitations of some regulatory companies, Advantages, disadvantages, what type problems are arises while establishing this setups for drug product production, method, application, and manufacturing risk are represented. It also gives information about the current status of 3D printing technology in research and development of drug products. For the fabrication of novel solid dosage form a number of 3D printing technology have been developed. This review is mainly focused on describing different technology used for the application of 3D printing in pharmaceutical industry [ABSTRACT FROM AUTHOR]

We theoretically and empirically study the effect of variation in regulatory review time on firms' choices between radical and incremental innovations. We differentiate between entry into new segments (the extensive margin) and increasing the number of innovations in a given sector (the intensive margin). Our theoretical investigation indicates additional entry into medical device segments as a result of shorter application review times. It also predicts firm-level substitution effect, suggesting firms shift their R&D to innovation applications with relatively shorter review times. To test the theoretical predictions, we utilize a unique data set from the U.S. Food and Drug Administration that contains all product market approvals in the high-risk medical device market for the 1978–2007 period. The empirical results generally support our theoretical predictions. However, the results also show that firms are more responsive to changes in the review time for incremental applications compared to radical ones. [ABSTRACT FROM AUTHOR]

Pediatric medical device approvals lag behind adult approvals. Historically, medical devices have rarely been designed specifically for children, but use in children has most often borrowed from adult or general use applications. While a variety of social, economic, and clinical factors have contributed to this phenomenon, the regulatory process remains a fundamental aspect of pediatric device development and commercialization. FDA's Center for Devices and Radiological Health (CDRH) has established programmatic and technological areas of advancement to support innovation that serves the public health needs of children and special populations. We highlight four regulatory areas that have the potential to shape the future of pediatric cardiology: the CDRH Early Feasibility Study Program, advancements in 3D printing or additive manufacturing, computational modeling and simulation, and the use of real-world evidence for regulatory applications. These programs have the potential to impact all stages of device development, from early conception, design, and prototyping to clinical evidence generation, regulatory review, and finally commercialization. The success of these programs relies on a collaborative community of stakeholders, including government, regulators, device manufacturers, patients, payers, and the academic and professional community societies. [ABSTRACT FROM AUTHOR]

We study the impact of regulating product entry and quality information requirements on an oligopoly equilibrium and consumer welfare. Product testing can reduce consumer uncertainty, but also increase entry costs and delay entry. Using variation between EU and US medical device regulations, we document patterns consistent with valuable learning from more stringent US requirements. To derive welfare implications, we pair the data with a model of supply, demand, and testing regulation. US policy is indistinguishable from the policy that maximizes total surplus in our estimated model, while the European Union could benefit from more testing. "Post-market surveillance" could further increase surplus. (JEL D43, I18, L13, L51, L64, O31, O38) [ABSTRACT FROM AUTHOR]

• A data-based decision algorithm is proposed. • Patient risk, treatment impact on harm and simulation maturity of harm are evaluated. • The method is illustrated with an end-to-end example. • The approach can be applied to any medical device. Clinical trials represent a crucial step in the development and approval of medical devices. These trials involve evaluating the safety and efficacy of the device in a controlled setting with human subjects. However, traditional clinical trials can be expensive, time-consuming, and ethically challenging. Augmenting clinical trials with data from computer simulations, so called in silico clinical trials (ISCT), has the potential to address these challenges while satisfying regulatory requirements. However, determination of the patient harms in scope of an ISCT is necessary to ensure all harms are sufficiently addressed while maximizing the utility of the ISCT. This topic is currently lacking guidance. The objective of this work is to propose a general method to determine which patient harms should be included in an ISCT for a regulatory submission. The proposed method considers the risk associated with the harm, the impact of the device on the likelihood of occurrence of the harm and the technical feasibility of evaluating the harm via ISCT. Consideration of the risk associated with the harm provides maximum clinical impact of the ISCT, in terms of focusing on those failure modes which are most relevant to the patient population. Consideration of the impact of the device on a particular harm, and the technical feasibility of modeling a particular harm supports that the technical effort is devoted to a problem that (1) is relevant to the device in question, and (2) can be solved with contemporary modeling techniques. As a case study, the proposed method is applied to a total shoulder replacement humeral system. With this framework, it is hoped that a consistent approach to scoping an ISCT can be adopted, supporting investment in ISCT by the industry, enabling consistent review of the ISCT approach across device disciplines by regulators, and providing maximum impact of modeling technologies in support of devices to improve patient outcomes. [ABSTRACT FROM AUTHOR]

It is especially difficult to identify predicate devices for older 510(k) medical devices, but predicate information for newer devices is also inconsistently available. Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance - Reply Comment & Response B In Reply b Dr Rathi's comments describe a fundamental challenge when studying 510(k) medical devices. [Extracted from the article]

Attention-deficit hyperactivity disorder (ADHD) with its high prevalence is a growing area of concern and research, whereas exact underlying pathophysiology remains unknown. Behavioral therapy and multiple medications include methylphenidate, atomoxetine, and amphetamines while trigeminal nerve stimulator (TNS) is the first medical device in ADHD with FDA approval. The aim of this article is to evaluate the latest studies in this field. [ABSTRACT FROM AUTHOR]

The article focuses on device development for gastrointestinal clinical care. It highlights the laws and regulations by the U.S. Food and Drug Administration (FDA) related to the approval of medical devices. It discusses the classification of medical devices by the FDA according to risks and level of controls involved in their safety and effectiveness, as of June 2021.

Genitourinary syndrome of menopause (GSM) is common and can be treated with over-the-counter vaginal lubricants or supplementation with vaginal estrogen. Three randomized controlled trials with 179 patients did not show a significant difference between vaginal laser treatment and vaginal hormone therapy.[6] However, a high-quality, sham-controlled randomized trial with 85 patients found that CO SB 2 sb laser treatment did not significantly improve GSM symptoms, quality of life or sexual function at 12 months, compared with the sham treatment. Patients who undergo energy-based vaginal rejuvenation therapy may be seeking treatment for GSM or urinary incontinence; their symptoms may not have been properly evaluated and they may not have been offered standard evidence-based treatments. [Extracted from the article]

The article discusses author's experiences for the approval of medical device. Topics include new levels of scrutiny and demand more clinical data for CE Certification; mentions clinical investigators for financial relationship to the manufacturer of the device; and Food and Drug Administration (FDA) approval for transcatheter aortic valve implantation (TAVI) in high risk patients.

The 21st Century Cures Act introduced innovative changes to the Food and Drug Administration's regulatory processes. In an effort to address the slow, costly, and burdensome approval process for high-risk devices, the Cures Act modernized clinical trial data by allowing reviewers to determine whether devices merit expedited review and to consider post-market surveillance data in the premarket approval process. These changes will get life-saving devices to the people who need them faster than ever before. But the tradeoff is a greater risk of injury to the patient. The 2008 Supreme Court decision Riegel v. Medtronic, Inc., held that any device receiving premarket approval is federally preempted from state tort claims. This means injured patients of medical device malfunctions are barred from seeking remedy against the manufacturers. Thus, the Cures Act potentially puts patients at greater risk, but does nothing to provide those patients remedies for injury. This Note argues that federal preemption for medical devices receiving premarket approval should be reconsidered. Because the regulatory framework for which Riegel was decided has now shifted, the Court should reevaluate its prior ruling. Additionally, Congress should amend the preemption clause in the Food, Drug, and Cosmetic Act to allow for state tort action. Finally, Congress should create a victim compensation fund, run by HHS, to allow victims to make nofault injury claims and receive payments for their suffering. [ABSTRACT FROM AUTHOR]

Commercialization has been slow since the FDA approved a medical device containing nanomaterials in 1980. In 2017, the FDA released draft guidance to accelerate approval. We highlight here that geographical and structural separation of researchers, manufacturers, and clinical servicers may slow commercialization more than FDA approval. [ABSTRACT FROM AUTHOR]