[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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