Although this device is not approved by the U.S. Food and Drug Administration (FDA), it might be possible to import it under an amendment to the Food, Drug, and Cosmetic Act (FD&CA).
This amendment provides a means by which individuals can import a prescription drug or device which is not approved by the FDA. The fact that the FDA may, in its discretion, may allow such importation does not legalize the drug or device.
As a practical matter, an individual in the U.S. would need a willing medical practitioner to write a prescription and there would have to be some form of documentation, such as the results of a Phase I clinical trial, explaining why the device "does not appear to present an unreasonable risk to the individual."
Although the FDA's Regulatory Procedures Manual (RPM) (see below) states that the exercise of its discretion is applicable to "a serious condition for which effective treatment may not be available domestically," the RPM is a "policy" rather than a "regulation," and the FDA enjoys virtually unfettered discretion on what unapproved drugs and devices it may allow individuals to import.
In real life, thousands and thousands of unapproved drugs and devices are imported daily, mainly be persons arriving abroad with such items in their baggage.
21 U.S.C. § 384 (j) Waiver authority for importation by individuals
Congress declares that in the enforcement against individuals
of the prohibition of importation of prescription drugs and
devices, the Secretary should -
(A) focus enforcement on cases in which the importation by an
individual poses a significant threat to public health; and
(B) exercise discretion to permit individuals to make such
importations in circumstances in which -
(i) the importation is clearly for personal use; and
(ii) the prescription drug or device imported does not
appear to present an unreasonable risk to the individual.
(2) Waiver authority
(A) In general
The Secretary may grant to individuals, by regulation or on a
case-by-case basis, a waiver of the prohibition of importation
of a prescription drug or device or class of prescription drugs
or devices, under such conditions as the Secretary determines
to be appropriate.
(B) Guidance on case-by-case waivers
The Secretary shall publish, and update as necessary,
guidance that accurately describes circumstances in which the
Secretary will consistently grant waivers on a case-by-case
basis under subparagraph (A), so that individuals may know with
the greatest practicable degree of certainty whether a
particular importation for personal use will be permitted.
In implementing 21 U.S.C. § 384 (j), the FDA's Regulatory Procedures Manual (RPM) (2011), Chapter 9, Import Operations and Actions, § 9-2, Coverage of Personal Importations, page 9-14 through page 9-15, states:
In deciding whether to exercise discretion to allow personal shipments of drugs or devices, FDA personnel may consider a more permissive policy in the following situations:
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2) a) the intended use is unapproved and for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means;
b) there is no known commercialization or promotion to persons residing in the U.S. by those involved in the distribution of the product at issue;
c) the product is considered not to represent an unreasonable risk; and
d) the individual seeking to import the product affirms in writing that it is for the patient's own use (generally not more than 3 month supply) and provides the name and address of the doctor licensed in the U.S. responsible for his or her treatment with the product, or provides evidence that the product is for the continuation of a treatment begun in a foreign country.