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The best treatment for a food allergy reaction is Epinephrine, also called "adrenaline," the medication of choice for controlling a severe reaction. It is available by prescription as a self-injectable device.
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FDA`s Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who sell and/or manufacture medical devices. According to the FDA there are three types of medical devices.
- Type I: General Controls - These types of devices are subject to the least regulatory control. They present minimal potential for harm to the user and are often simpler in design. (ex. bandages, hand-held surgical instruments).
- Type II: Special Controls - These devices are those for which general controls alone are insufficient to assure safety and effectiveness, and existing methods are available to provide such assurances. Special controls may include special labeling requirements, mandatory performance standards and post-market surveillance. (ex. infusion pumps)
- Type III: Pre-market Approval - Devices in which insufficient information exists to assure safety and effectiveness solely through general or special controls (ex. heart valves, breast implants)
The MediCard is a Type II device. Type II devices typically go through an FDA process known as a Premarket Notification 510(k), where if cleared will receive a letter of substantial equivalence (a clearance). Until a firm receives a letter of substantial equivalence from the FDA, it can not commercially distribute the device. A 510(k) must demonstrate that the device is substantially equivalent to one legally in commercial distribution in the United States.
The substantially equivalent device is a Type II device; Product Code NSC; and with a Device Name Injector, Pen. It is regulated by Regulation number 880.5860. The definition given by the FDA matches exactly what the MediCard is:
A pen injector is a device that provides a nonelectrically-powered, mechanically-operated method of accurately injecting a dose of medicinal product from a medicinal cartridge, reservoir, or syringe through a manually-inserted single lumen hypodermic needle. The device can be used by health professionals or for self-injection by the patient.
Therefore, we believe that the MediCard will successfully go through a 510(k) process which typically takes 45 – 120 days. We expect to use an FDA Accredited third party to review our submission. This will accelerate the process, as the FDA must respond within 30 days of the 3rd part’s review.
http://www.fda.gov/cdrh/devadvice/overview.html
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=2239
http://www.fda.gov/cdrh/thirdparty/ |
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Product Description
FDA - Regulations 
