CDRH Humanitarian Device Exemptions
The identified humanitarian device approved by the FDA in the past decade is Minimally Invasive Deformity Correction (MID-C) System. According to the U.S. Food and Drug Administration (2020), the MID-C system refers to a non-unification spinal tool used in the prevention of spinal curve continuity among adolescent patients who have idiopathic scoliosis. Research shows that the MID-C system encompasses a ratcheting rod derived from titanium alloy constituents linked to the spine by the help of screws (U.S. Food and Drug Administration, 2020).
The MID-C System is used in the treatment of a condition known as scoliosis. Idiopathic scoliosis causes the spinal bones to rotate or twist so that rather than having a straight line along the center of the back, the spine ends up looking like a letter “C” or “S.” More often, the scoliosis curves happen in the middle and upper back around the thoracic spine. Sometimes, these curves can also grow in the lower back (Van Norman, 2016). Occasionally, the scoliosis curves will happen in both the lower and upper sections of the spine. Idiopathic scoliosis curves occur in different sizes, and mild curves often characterize it. It is a condition that can worsen if a child is growing. While idiopathic scoliosis is a common condition among toddlers and developing children, it mostly starts at puberty. Additionally, both girls and boys can get affected, but girls are more susceptible to grow larger curves that need medical attention (OrthoInfo, 2020).
The MID-C System meets the HDEs’ requirements by addressing all the concerns enshrined HUDs such as the FDA actions. This humanitarian device reflects the alterations in the HDE programs leading to the proper implementation of statutory amendments as captured in the 21st Century Cures Act, which is commonly known as Cures Act (Lauer et al., 2017).
References
Lauer, M., Barker, J. P., Solano, M., & Dubin, J. (2017). FDA Device Regulation. Missouri medicine, 114(4), 283.
OrthoInfo (2020). Our knowledge of orthopaedics. Your best health. Retrieved August 28, 2020, from https://orthoinfo.aaos.org/en/diseases–conditions/idiopathic-scoliosis-in-children-and-adolescents/
U.S. Food and Drug Administration (2020). Listing of CDRH Humanitarian Device Exemptions. Retrieved August 28, 2020, from https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions
Van Norman, G. A. (2016). Drugs, devices, and the FDA: part 2: an overview of approval processes: FDA approval of medical devices. JACC: Basic to Translational Science, 1(4), 277-287.