The mission of Food and Drug Administration (FDA)\'s Center for Devices and Radiological Health is to protect and promote public health. It assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products by providing meaningful and timely information about the products we regulate and the decisions we make. On September 17, 2021, an FDA workshop was held to provide information to stakeholders, including members of the spine community, device manufacturers, regulatory affairs professionals, clinicians, patients, and the general public regarding FDA regulations, guidance and regulatory pathways related to spinal device clinical review. It was not intended to communicate any new policies, processes, or interpretations regarding medical device marketing authorizations. This workshop consisted of individual presentations, group discussions, question and answer sessions, and audience surveys. Information-sharing included discussions related to patient-reported outcomes, clinician-reported outcomes, observer-reported outcomes, and performance outcomes. Discussions involving external subject matter experts covered topics related to spinal device clinical studies including definition of a target population, enrollment criteria, strategies for inclusion of under-represented patient groups, reporting of adverse event and secondary surgical procedures, clinical study endpoints, and clinical outcome assessments. A meeting transcript and webcast workshop link are currently posted on the FDA website. Important related issues and challenges were discussed, and an exciting range of new ideas and concepts were shared which hold promise to advance regulatory science, patient care and future innovation related to spinal devices.

Academic researchers concentrate on the scientific and technological feasibility of novel treatments. Investors and commercial partners, however, understand that success depends even more on strategies for regulatory approval, reimbursement, marketing, intellectual property protection and risk management. These considerations are critical for technologically complex and highly invasive treatments that entail substantial costs and risks in small and heterogeneous patient populations. Most implanted neural prosthetic devices for novel applications will be in FDA Device Class III, for which guidance documents have been issued recently. Less invasive devices may be eligible for the recently simplified \"de novo\" submission routes. We discuss typical timelines and strategies for integrating the regulatory path with approval for reimbursement, securing intellectual property and funding the enterprise, particularly as they might apply to implantable brain-computer interfaces for sensorimotor disabilities that do not yet have a track record of approved products.

OBJECTIVE: The US FDA uses evidence from clinical trials in its determination of safety and utility. However, these trials have often suffered from limited external validity and generalizability due to unrepresentative study populations with respect to clinical patient demographics. Section 907 of the FDA Safety and Innovation Act (FDASIA) of 2012 attempted to address this issue by mandating the reporting of certain study demographics in new device applications. However, no study has been performed on its effectiveness in the participant diversity of neurosurgical device trials.
METHODS: The FDA premarket approval (PMA) online database was queried for all original neurosurgical device submissions from January 1, 2006, to December 31, 2019. Endpoints of the study included racial and gender demographics of reported effectiveness trials, which were summated for each submission. Chi-square tests were performed on both endpoints for before and after years of FDASIA passage and implementation.
RESULTS: A total of 33 device approvals were analyzed, with 14 occurring before SIA implementation and 19 after. Most trials (96.97%) reported gender to the FDA, while 66.67% reported race and 63.64% reported ethnicity. Gender breakdown did not change significantly post-SIA (53.30% female, p = 0.884). Racial breakdown was significantly different from the 2010 US Census for all races (p < 0.001) both pre- and post-SIA. Only Native American race was significantly different in terms of representation post-SIA, increasing from 0% to 0.63% (p = 0.0187). There was no significant change in ethnicity.
CONCLUSIONS: The FDASIA, as currently written, does not appear to have had a significant impact on the racial or gender diversity of neurosurgical device clinical trial populations. This may be due to the noncompulsory nature of its guidance, or a lack of more stringent regulation on the composition of clinical trials themselves.

The medical device industry has long been subject to criticism for lack of price transparency and minimal regulations surrounding device approval, which have functioned as barriers to providing quality and cost-effective care. Recent health care reforms aimed at overcoming these barriers, including improving market approval regulations, increasing postmarket surveillance, and using comparative effectiveness research, have drastically changed industry practices. These reforms have also prompted increasingly cost-aware health care practices, which have encouraged new trends in medical device innovation such as frugal innovation and deinstitutionalization. This article explores the challenges faced by industry, physicians, and patients in light of these reforms.

Introduction Innovations in cancer treatment coupled with an increasing number of cancer patients have led to the growth of brachytherapy devices. The objective of this study is to characterize the development and safety of brachytherapy devices marketed in the United States (US) over the last 15 years. Methods We reviewed records from a public US Food and Drug Administration (FDA) database detailing premarket approval of brachytherapy devices. All 510(k) submissions approved between January 1, 2000 and October 31, 2018 were examined. To assess the safety of these devices, we searched the manufacturer and user facility device experience (MAUDE) database for related adverse events. Results Twenty-two brachytherapy devices received 510(k) premarket approval, with the first device approved in 2005. Of the 22 devices, 20 (91%) were marketed with specific indications. The most common indications include treatment of skin cancers and keloids (n=7), breast cancer (n=4), and gynecologic/rectal cancers (n=2). A review of the MAUDE database revealed 64 reports of adverse events associated with brachytherapy devices. Common adverse effects include poor device design, use error, and device malfunction that led to the delivery of an inaccurate dose of radiation. Discussion Although there are some single-center, short-term studies demonstrating adequate local control and satisfactory cosmesis with brachytherapy, data on long-term outcomes are lacking. Further research is warranted to define appropriate practice guidelines for brachytherapy devices in the treatment of various malignancies.

Introduction: Powered muscle stimulators have been popularized in recent years due to their muscle toning effects. This study aims to describe marketing trends and reporting of adverse effects of powered muscle stimulators.Methods: We performed a cross-sectional retrospective analysis of records from the United States FDA database for 510(k) premarket approval of powered muscle stimulators between January 1, 2000 and December 31, 2018. The FDA MAUDE database was reviewed for adverse events reported with device usage.Results: One hundred and seventeen devices received 510(k) premarket approval between 2000 and 2018, with the first approval occurring in 2001. Initially, devices were marketed to assist with muscle toning and strengthening, but more recent indications include the treatment of pain, increased local muscle blood circulation, and prevention of post-surgical venous thrombosis. Thirty-six adverse event reports have been submitted and published in the MAUDE database over the past 10 years by 11% of manufacturers.Discussion: Powered muscle stimulators are growing increasingly popular amongst consumers and healthcare providers due to their ease of use and perceived esthetic, muscle strength, and pain relief benefits. Additional investigation to determine optimal treatment parameters and potential adverse effects is necessary due to the growing popularity of these devices.

To assess the methodological quality of pre-market clinical studies performed on medical devices (MDs), including in-vitro diagnostic (IVD) MDs, in Europe.
Observational cross-sectional study.
A large German ethics committee.
From the consecutive sample of study applications between March 2010 and December 2013, we selected MD study applications requiring approval by an ethics committee and the competent federal authority. These included pre-market studies on devices that had not yet received a CE (Conformité Européenne) mark or had previously been CE marked for a different indication. Also included were post-CE studies requiring federal authority approval because the study entailed additional invasive or otherwise burdensome components.
Besides the design of the studies, we assessed the planned sample size, study duration and other aspects.
122 study applications were analysed: 98 (80%) concerned therapeutic rather than diagnostic devices and 84 (69%) were pre-market studies. The proportion of studies on class I, IIa, IIb and III devices was 10%, 15%, 28% and 39%, respectively. 10 studies (8%) investigated IVD MDs. A randomised controlled trial (RCT) was planned in 70 (57%) of the 122 applications; studies with non-randomised control groups (n=23; 19%) or without controls (n=29; 24%) were less common. In the sub-group of pre-market studies on therapeutic devices, the proportion of RCTs was 66% (43/65). The median sample size was 120 participants or samples (IQR 53-229). The median study duration was 24 (14-38) months. 87 studies (71%) considered at least one patient-relevant outcome. 12 (17%) and 37 (53%) of the 70 RCTs applied a fully or partially blinded design, respectively.
A large proportion of MD studies in Germany apply a randomised controlled design, thus contradicting the industry argument that RCTs on MDs are commonly infeasible.

Introduction: Greater demand for noninvasive techniques to reduce cellulite and contour the body has led to the growth of electromagnetic and radiofrequency devices. In this study, we aimed to characterize the evolution and safety of electromagnetic devices marketed in the U.S. over the last two decades. Methods: We examined records from a U.S. FDA database documenting premarket approval of electromagnetic devices between January 1, 2000 and October 31, 2018. Additionally, we searched the Manufacturer and User Facility Device Experience (MAUDE) database for reports of adverse events. Results: Thirty-one devices were approved from 2012-2018. Initially marketed to temporarily reduce muscle pain and cellulite, indications for these devices have expanded. The MAUDE database revealed 61 reports of adverse events including acute skin damage, dyspigmentation, infection, hair growth, scarring, and others. Discussion: Although electromagnetic devices are gaining increasing public attention and marketed to be safe, the frequency and types of adverse events are not well-documented. Importantly, the MAUDE database has limitations including submission of incomplete, inaccurate, untimely, or unverified data make determining the true number of adverse events difficult. Further investigation is greatly needed to define appropriate parameters and outcomes for the use of electromagnetic devices in body contouring and skin enhancement.

Medical devices are essential in the diagnosis and treatment of otolaryngologic disease. The US Food and Drug Administration (FDA) is tasked with assuring the safety and effectiveness of these devices. Otolaryngologists, in turn, are often responsible for helping patients understand risks, benefits, and alternatives when deciding whether to rely on devices in their care. To best counsel patients, otolaryngologists should be aware of the strengths and limitations of device regulation by the FDA. This article reviews the FDA regulatory framework for medical devices, premarket evidentiary standards for marketing devices, and postmarket methods of safety surveillance.

The regulatory field for digital pathology (DP) has advanced significantly. A major milestone was accomplished when the FDA allowed the first vendor to market their device for primary diagnostic use in the USA and published in the classification order that this device, and substantially equivalent devices of this generic type, should be classified into class II instead of class III as previously proposed. The Digital Pathology Association (DPA) regulatory task force had a major role in the accomplishment of getting the application request for Whole Slide Imaging (WSI) Systems recommended for a de novo. This article reviews the past and emerging regulatory environment of WSI for clinical use in the USA. A WSI system with integrated subsystems is defined in the context of medical device regulations. The FDA technical performance assessment guideline is also discussed as well as parameters involved in analytical testing and clinical studies to demonstrate that WSI devices are safe and effective for clinical use.