[Federal Register Volume 62, Number 92 (Tuesday, May 13, 1997)]
[Rules and Regulations]
[Pages 26228-26229]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-12524]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 812


Export Requirements for Medical Devices; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending its 
regulations for exporting devices for investigational use to correct 
the statutory reference. This action is being taken to reflect changes 
in the Federal Food, Drug, and Cosmetic Act (the act), and to ensure 
the accuracy and consistency of the regulations.

EFFECTIVE DATE: May 13, 1997.

FOR FURTHER INFORMATION CONTACT: Philip L. Chao, Office of Policy (HF-
23), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20850, 301-827-3380.

SUPPLEMENTARY INFORMATION: At present, two statutory provisions in the 
act govern the export of devices that are not approved for marketing in 
the United States. The first provision, at section 801(e)(2) of the act 
(21 U.S.C. 381(e)(2)), became law as part of the Medical Device 
Amendments Act of 1976 (Pub. L. 94-295) and required FDA's approval of 
certain exports of unapproved devices.
    The second provision, now codified as section 802 of the act (21 
U.S.C. 382), was the result of the FDA Export Reform and Enhancement 
Act of 1996 (Pub. L. 104-134, and amended by Pub. L. 104-180) (the 
Export Act of 1996). The Export Act of 1996 amended, among other 
things, sections 801 and 802 of the act. The Export Act of 1996 amended 
section 801(e)(2) of the act to state, in part, that export of an 
unapproved device may occur only if the agency determines that 
exportation of the device is not contrary to the public health and 
safety and has the approval of the country to which it is intended for 
export or ``the device is eligible for export under section 802'' of 
the act. Section 802 of the act, as amended, authorizes exports of 
unapproved drugs and devices if certain conditions or requirements are 
met. Under section 802(b)(1) of the act, an unapproved device may be 
exported to any country if the device complies with the laws of that 
country and has valid marketing authorization in Australia, Canada, 
Israel, Japan, New Zealand, Switzerland, South Africa, or in any 
country in the EU or the EEA (often referred to as the ``listed 
countries''). At present, the EU countries are Austria, Belgium, 
Denmark, Germany, Greece, Finland, France, Ireland, Italy, Luxembourg, 
the Netherlands, Portugal, Spain, Sweden, and the United Kingdom. The 
EEA countries are the EU countries, plus Iceland, Liechtenstein, and 
Norway. As new countries join the EU or the EEA, they will 
automatically be treated as listed countries without any need for FDA 
action. Additionally, the Secretary of Health and Human Services may 
designate additional countries to be added to the list if certain 
requirements are met.
    Other provisions of the Export Act of 1996 permit devices to be 
exported, without prior FDA approval, for investigational use in the 
listed countries and to be exported in anticipation of market 
authorization in the listed countries (section 802(c) and (d) of the 
act). Prior FDA approval is required for devices intended for use in 
the treatment of a tropical disease or a disease that is not of 
significant prevalence in the United States (section 802(e) of the 
act).
    All devices exported under section 802 of the act are subject to 
certain requirements, under section 802(f) of the act. For example, the 
device must be manufactured, processed, packaged, and held in 
substantial conformity with current good manufacturing practice 
requirements or meet international standards as certified by an 
international standards organization recognized by the agency; must not 
be adulterated under section 501(a)(1), (2)(A), or (3) (21 U.S.C. 
351(a)(1), (2)(A), or (3)) or section 501(c) of the act; and must 
comply with sections 801(e)(1)(A) through (D) of the act (which require 
the

[[Page 26229]]

device to accord to the foreign purchaser's specifications, not be in 
conflict with the laws of the foreign country to which the device is 
being exported, be labeled on the outside of the shipping package that 
the device is intended for export, and not be sold or offered for sale 
in domestic commerce).
    The only regulation pertaining to exports of unapproved devices for 
investigational use is at 21 CFR 812.18(b). The provision, which was 
originally written decades ago, simply stated that, ``A person 
exporting an investigational device subject to this part shall obtain 
FDA's prior approval as required by section 801(d) of the act.'' 
However, since the provision was written, Congress has amended the act 
twice; under the Drug Export Amendments Act of 1986, section 801(d) of 
the act was renumbered to become section 801(e) of the act, and the 
Export Act of 1996 established section 802 of the act as an alternative 
export mechanism for unapproved devices for investigational use. 
Consequently, FDA is amending Sec. 812.18(b) to state that, ``A person 
exporting an investigational device subject to this part shall obtain 
FDA's prior approval as required by section 801(e) of the act or shall 
comply with the applicable export requirements in section 802 of the 
act.'' This amendment reflects the correct paragraph in section 801 of 
the act that applies to investigational device exports as well as the 
export mechanisms in section 802 of the act.
    Publication of this document constitutes final action on these 
changes under the Administrative Procedure Act (5 U.S.C. 553(b)(3)(B)). 
Notice and public procedure are unnecessary because FDA is merely 
correcting a statutory reference.

List of Subjects in 21 CFR Part 812

    Health records, Medical devices, Medical research, Reporting and 
recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
812 is amended as follows:

PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS

    1. The authority citation for 21 CFR part 812 is revised to read as 
follows:

    Authority: Secs. 301, 501, 502, 503, 505, 506, 507, 510, 513-
516, 518-520, 701, 702, 704, 721, 801, 802, 803 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 331, 351, 352, 353, 355, 356, 357, 
360, 360c-360f, 360h-360j, 371, 372, 374, 379e, 381, 382, 383); 
secs. 215, 301, 351, 354-360F of the Public Health Service Act (42 
U.S.C. 216, 241, 262, 263b-263n).

    2. Section 812.18 is amended by revising paragraph (b) to read as 
follows:

Sec. 812.18  Import and export requirements.

* * * * *
    (b) Exports. A person exporting an investigational device subject 
to this part shall obtain FDA's prior approval, as required by section 
801(e) of the act or comply with section 802 of the act.

    Dated: May 6, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-12524 Filed 5-12-97; 8:45 am]
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