Medical Device Authorization (MDA)

Why must I be verified to purchase certain products?

Prescription Devices are regulated both by Federal and state law. To ensure compliance with those laws, North American Rescue has a verification process that must be completed before you may purchase Prescription Devices.

What are the laws?

The Food and Drug Administration requires prescription devices be

  • (1) “in the possession of a person (including agents and employees) regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale or retail distribution of such devices,” or
  • (2) “in the possession of a practitioner, such as physicians, dentists, and veterinarians, licensed by [state] law to use or order the use of such devices.” 21 C.F.R. § 801.109.

FDA also requires that prescription devices be “sold only to or on the prescription or other order of such practitioner for use in the course of his professional practice.” Id. There is an exception to this rule for medical devices intended for use only in teaching, law enforcement, research, and analysis. Id. § 801.125. In addition, states often have requirements for Prescription Devices.

I am a Paramedic, Combat Medic, Law Enforcement Officer, etc. Can I purchase Prescription Devices for personal use?

You may only purchase Prescription Devices for personal use if you have a valid National Provider Identifier (NPI). Although you may be authorized to use Prescription Devices in your professional capacity, that authorization generally flows from working under the direction of a licensed practitioner (e.g., as a paramedic for an agency with a medical director) or from your occupation (e.g., as a law enforcement officer in the performance of duty per 21 C.F.R. § 801.125). That authorization does not extend to use outside of that professional capacity.

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