CurvRITE Growth Guidance System developed by SpineGuide, a domestic medical device enterprise focusing on the research and development of spine products, obtained the FDA designation as a Breakthrough Device on Sep 11, 2023. CCRC is pleased to have helped SpineGuide to successfully tap into the U.S. market within the expected time frame.
[The First Self-Extending 3D Orthopedic Growth Guidance System in the World]
Scoliosis is a sideways curvature of the spine that most often is diagnosed in adolescents who are at rapid growth and development age, causing abnormal body appearance such as uneven backs and unequal shoulders. An especially serious spinal curve can reduce the amount of space within the chest, making it difficult for the heart and the lungs to function properly and affecting labor capacity.. Besides, it may also cause other spine disorders and mental illness. Scoliosis in children under 10 years of age is also known as early onset scoliosis (EOS). Spinal fusion is the traditional and the most common surgery for scoliosis. It can effectively correct the deformity, but the spine will no longer grow. The conventional growing rod cannot extend by itself, so multiple surgeries are needed to artificially extend the growing rod, which causes a lot of sufferings and a heavy burden to the patients. Different from other similar commercially available devices, CurvRITE system offers a one-step solution that, while providing a unique 3D orthosis, it allows the growing rod to extend as the spine grows, avoiding the pain of repeated surgery for the patients, which meet the current unmet need in clinical practice.
CCRC Provided Professional Regulation and Medical Assistance
CCRC medical team and regulatory affairs team provided high-caliber guidance to SpineGuide throughout the whole process of FDA breakthrough device request and designation. In the case that there are already two similar devices that had been approved in the United States, and that no large-scale clinical study or any US clinical trial on the subject product for registration has been conducted, CCRC regulatory affairs team and medical team have helped SpineGuide successfully get the FDA’s innovative device designation by using their strong logical analysis of the non-clinical studies, simulation trials, clinical literatures, and FIH studies.
What is FDA Breakthrough Devices Program?
The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
The Breakthrough Devices Program is intended to provide patients and health care providers with timely access to medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization. Breakthrough Devices must meet the rigorous standards of the US Food and Drug Administration (FDA) for device safety and effectiveness in order to be authorized for marketing. The Breakthrough Devices Program reflects FDA’s commitment to device innovation and protecting the public health.
The Breakthrough Devices Program replaces the Expedited Access Pathway and Priority Review for medical devices. The FDA considers devices granted designation under the Expedited Access Pathway to be part of the Breakthrough Devices Program.
Benefits of the Breakthrough Devices
1. Interactive and Timely Communication
The Breakthrough Devices Program offers the applicants an opportunity to interact with FDA experts through several different program options.
2. Pre/Postmarket Balance of Data Collection
For products that meet the criteria for premarket approval request, FDA plans to use post-market data to bring products to market in a timely and more efficiently manner while ensuring scientific review.
3. Efficient and Flexible Clinical Study Design
For innovative devices, FDA intends to “take steps to ensure that the design of clinical trials is as efficient and flexible as practicable, when scientifically appropriate.”
In addition to the above advantages, the approach of breakthrough device request and designation also provide benefits such as review team support and priority review, which can not only help enterprises to get into the US market faster and more efficiently, but also have positive effect on the reputation of the enterprises and the development of subsequent generations of the products.
CCRC Regulatory Affairs Team
Working experience of CCRC Regulatory Affairs Team includes projects for passive devices, active devices, software devices, in vitro diagnostic reagents and instruments, and GMP system establishment, etc. Besides, the team has a specially designated member to maintain its regulatory think tanks, tracking the updates of Chinese medical device regulations and providing interpretation in real time. They are committed to provide high-quality services on medical device product registration in China, the United States, and European Union, as well as quality management system, human genetic data approval and filing, and regulations related consulting services.
All members of the team are senior regulatory practitioners, with years of front-line experience in regulatory institutions, testing agencies and manufacturing enterprises. With in-depth understanding of medical device review keypoints, product registration technical review guidelines and standards, as well as medical product administration policies and requirements, this team can help companies to develop registration strategies, address technical challenges and review essential documents in preclinical and clinical research stages.