In the United States, most upper and lower extremity prosthetic components are regulated as Class I (exempt) medical devices. The Federal Food and Drug Administration in the US (FDA), classifies medical devices as Class I, II or III. While most Class I devices are subject to the full set of general controls, including that they be "manufactured under a quality assurance program, be suitable for the intended use, be adequately packaged and properly labeled, and have establishment registration and device listing forms on file with the FDA." prosthetic components and a few other devices are exempt from these general requirements and subject only to record keeping (21CFR820.180) and complaint file (21CFR820.198) requirements, as stated in the Code of Federal Regulations, Title 21, Chapter I, Subchapter H, Part 890, Subpart D, Physical Medicine Prosthetic Devices, Sec. 890.3420, External limb prosthetic component, or 21CFR890.3420. This section states that these devices are exempt from premarket approval or 510(k) requirements, except as provided in 21CFR890.9, which allows this exemption as long as the new device has "existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type," it is intended for the same use and the same user type as existing products, and the device operates on the same fundamental scientific technology. As this document from CIGNA (interesting for other reasons) points out, prostheses in their entirety are not mentioned, but all prosthetic device components are included.
Custom, Investigational or Experimental Devices
There are no regulations regarding custom parts made by prosthetic technicians and included in a completed prosthesis, or to customization of parts after distribution by a registered establishment. While it could be construed from the language in the exemption from the general controls above (which subject prosthetic limb component manufacture only to parts 820.198 and 820.180, and do not mention facility registration, included in the general controls), it is reasonable to assume that establishment registration is required. TRS Inc., or Therapeutic Recreation Systems Inc., run by amputee Bob Radocy in Colorado, for example, is registered with owner/operator and registration number 1718966. Interestingly enough, the establishment registration requirement prohibits publishing or broadcasting the registration number in any way, presumably to avoid any suggestion that the establishment or the device has been approved by the FDA. Prosthetic service providers routinely customize, modify and fabricate items for prosthetic use, and we are unaware of any that are registered as manufacturing establishments.
Because we are interested here at OPP in improving these devices, the obvious question arises: what about the testing of prototypes and their distribution to patients? Because we are dealing with a Class I (exempt) medical device that doesn't require a 510(k) submission, it could reasonably be argued that one need not do anything, because the rules governing Investigational Device Exemptions (IDEs) deal with the steps that must be taken in order to collect the data that must be submitted with the (not required) 510(k) application. These steps require that an Institutional Review Board (IRB) approve a study, that the patients are consented, the devices properly labeled for investigational use, the study is monitored, and that required records and reports are maintained. If these steps are complied with, the manufacturer need not even be a registered manufacturer as required above. It might reasonably be argued that for a device for which there are no requirements other than those outlined above, that a subset of these requirements might reasonably be complied with, e.g.: consent the patients, label the devices, and maintain records and reports on the use of the devices.
As we develop a procedure for dealing with this, we will make our decisions and documents available for others to use as a reference.