Description of FDA Category
Because there are a variety of commercially-available powered and mechanical prosthetics, it is believed that this device should not require pre-market approval (PMA). Since this is a joint effort between our team and Case Western, it is understood that they will be responsible for bringing the product or certain components of this project to market. Many similar devices in this space have been approved in the past, so the process should be expedited. As of April 2018, the FDA classifies “external limb prosthetic components” as being Class I devices. These devices include but are not limited to “ankle, foot, hip, knee, and socket components; mechanical or powered hand, hook, wrist unit, elbow joint, and shoulder joint components; and cable and prosthesis suction valves [1].” Our project falls under the criteria outlined above, so we may (at most) require 510(k) approval.
[1] “CFR – Code of Federal Regulations Title 21.” Accessdata.fda.gov, www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=890.3420.