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.

Thoracolumbosacral pedicle screw systems (TPSSs) are spinal implants commonly utilized to stabilize the spine as an adjunct to fusion for a variety of spinal pathologies. These systems consist of components including pedicle screws, rods, hooks, and various connectors that allow the surgeon to create constructs that can be affixed to a wide range of spinal anatomy. During the development and regulatory clearance process, TPSSs are subjected to mechanical testing such as static and dynamic compression bending per ASTM F1717, axial and torsional grip testing per ASTM F1798, and foam block pullout testing per ASTM F543. In this study, design and mechanical testing data were collected from 200 premarket notification (510(k)) submissions for TPSSs submitted to FDA between 2007 and 2018. Data were aggregated for the most commonly performed mechanical tests, and analyses were conducted to assess differences in performance based on factors such as component type, dimensions, and materials of construction. Rod material had a significant impact on construct stiffness in static compression bending testing with cobalt chromium rods being significantly stiffer than titanium rods of the same diameter. Pedicle screw type had an impact on compression bending yield strength with monoaxial screws having significantly higher yield strength as compared to polyaxial or uniplanar screws. Axial and torsional gripping capacities between components and the rods were significantly lower for cross-connectors than the other component types. The aggregated data presented here can be utilized for comparative purposes to aid in the development of future TPSSs.

The United States Food and Drug Administration (FDA) reviews class III orthopedic devices submitted for premarket approval with pivotal clinical trials. The purpose of this study was to determine the types of orthopedic devices reviewed, the design of their pivotal clinical trials, and the subjective factors affecting the interpretation of clinical trial data.
Meetings of the FDA Orthopaedic and Rehabilitation Devices Panel were identified from 2000-2016. Meeting materials were collected from FDA electronic archives and notes were made regarding the device-type and subsequent approval and recall, the design of pivotal clinical trials, and issues of trial interpretation debated during panel deliberations.
The panel was convened on 29 separate occasions over the course of 35 days to deliberate 38 distinct topics. Of these, 23 topics included clinical data submitted for approval of a device, and two topics were excluded. Of the 23 devices, five were biologic, three were hip arthroplasty, three were disc arthroplasty, two were viscosupplementation, three were interspinous process devices, and seven were other devices. Of the 23 pivotal trials, 20 (87.0%) were randomized controlled trials (RCTs), consisting of 13 (65.0%) non-inferiority trials and 7 (35.0%) superiority trials, and all RCTs were two-arm trials. At panel, the most commonly debated issues were related to the design and interpretation of non-inferiority trials.
A broad array of device types is reviewed by the FDA. The predominance of two-arm non-inferiority trials as pivotal studies indicates that the nuances of their design and interpretation are commercially important.

Spinal pathology and related symptoms are among the most common health problems and are associated with high health care costs and productivity losses. Due to the aging population, these costs are further increasing every year. Another important reason for the increasing costs is the market approval of new technologies, such as spinal devices that are usually more expensive than the existing technologies. Previous cases of medical device failure led to concern about possible deficiencies in the market approval process.
The objective is to provide an overview of U.S. Food and Drug Administration (FDA) regulation regarding spinal implants to delineate the challenges and opportunities that spine surgery currently faces.
In this paper, two cases of market entries of spinal devices are presented and evaluated to illustrate these deficiencies.
Spinal implant regulation is facing several challenges. New spinal devices should increase patient outcomes and safety at reasonable societal costs. The main challenge is to have a rigorous evaluation before dissemination, while still leaving room for innovative behavior that thrusts the healthcare practice forward.
We have provided recommendations to enhance spinal implant regulation and improve and ensure the patient\'s safety and the future of spine surgery.

Standards are important tools in evaluating and predicting the performance of medical devices prior to implantation. There are three types of standards that are available: a material specification, a standard test method, and a standard test guide. Each of these types of standards is defined with examples of how each is used to facilitate evaluation of medical devices. The standards development process is also described: this is a complex process, requiring the involvement of a multidisciplinary team, usually consisting of engineers, scientists, and clinicians who represent healthcare, academia, government, and industry. Finally, standards have a clear and defined role in the development of medical devices, and the benefits, strengths, as well as the limitations in this role are discussed.

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