[Federal Register Volume 62, Number 4 (Tuesday, January 7, 1997)]
[Proposed Rules]
[Pages 953-955]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-292]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 812

[Docket No. 95N-0342]


Export Requirements for Medical Devices; Reopening of Comment 
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening for 60 
days the comment period for a proposed rule that appeared in the 
Federal Register of November 27, 1995 (60 FR 58308). The document 
proposed to amend FDA's regulations for investigational devices to 
streamline requirements for persons seeking to export unapproved 
medical devices. FDA is seeking comments on whether this rulemaking is 
still needed in light of recent changes in the export provisions of the 
Federal Food, Drug, and Cosmetic Act (the act).

DATES: Written comments by March 10, 1997.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

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, electronic mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. The National Performance Review and the Proposed Rule on Device 
Exports

    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, in 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 approval of certain exports of 
unapproved devices. The second provision, in section 802 of the act (21 
U.S.C. 382), was the result of the FDA Export Reform and Enhancement 
Act of 1996 (the Export Act of 1996) (Pub. L. 104-134, and amended by 
Pub. L. 104-180).
    Before the latter provision became law, FDA had undertaken a 
program to streamline the requirements for the exportation of 
unapproved devices under section 801(e) of the act. In the Federal 
Register of November 27, 1995 (60 FR 58308), FDA issued a proposed rule 
to simplify the agency's export approval process for certain unapproved 
devices. The proposed rule was intended, in part, to respond to 
concerns in the device industry that the statutory requirement of FDA 
approval of device exports may undermine a firm's ability to compete in 
international markets and may represent an unnecessary regulatory 
barrier. (It should be emphasized, however, that FDA's approval times 
for device export applications have decreased significantly, from an 
average of 91 days per request in 1992 to 10 days in 1995, and further 
decreased to 8 days in fiscal year 1996.)
    The proposed rule was also intended to implement part of the 
President's and Vice-President's ``National Performance Review'' 
pertaining to the exportation of unapproved devices (as announced in an 
April 1995 report entitled ``Reinventing Drug and Device 
Regulations''). Under the National Performance Review, the agency would 
permit the export of unapproved devices to certain advanced 
industrialized countries without prior FDA review and approval, 
provided that the device complied with the importing country's laws. 
The report also stated that the Administration would seek the necessary 
legislative changes and would consult Congress on the appropriate list 
of advanced industrialized countries. Furthermore, the report stated 
that FDA would initiate administrative changes to permit exports to 
countries that are not on the list of advanced industrialized countries 
``if the exporter has an investigational device exemption (IDE) 
permitting testing on humans in the United States, the importing 
country has given FDA a letter providing blanket approval for IDE-type 
devices, and the device is in compliance with the importing country's 
laws.''
    To implement the administrative reform aspects of the report, FDA 
proposed to amend Sec. 812.18 (21 CFR 812.18) to state that a person 
who wishes to export an investigational device subject to part 812--
Investigational Device Exemptions (21 CFR part 812) must comply with 
the requirements in section 801(e)(1) of the act, but that, for 
purposes of section 801(e)(2), prior FDA approval would be unnecessary 
if the investigational device to be exported is the subject of an 
approved IDE (including nonsignificant risk devices which, under FDA 
regulations, are considered to have an approved IDE) and ``will be 
marketed or used in clinical trials in the foreign country for the same 
intended use as that in the approved IDE and is to be exported to a 
country that has expressed its approval of the importation of 
investigational devices'' that are the subject of an approved IDE. The 
proposed rule also stated that, if the device is the subject of an 
approved IDE and has received a ``CE'' mark from the European Union 
(EU), the device may be exported to any country in the European 
Economic Area (EEA).
    Proposed Sec. 812.18(b)(1) also would have FDA's Center for Devices 
and Radiological Health (CDRH) make available a list of countries that 
have approved the importation of investigational devices that are the 
subjects of approved IDE's. The list would be maintained 
electronically.
    Proposed Sec. 812.18(b)(2) would require prior FDA approval to 
export an investigational device if FDA withdrew approval of the IDE or 
the sponsor terminated any or all parts of investigations because 
unanticipated adverse device effects present an unreasonable risk to 
subjects.
    In the preamble to the proposed rule, FDA also stated that it would 
amend the proposed rule to reflect any legislative changes (60 FR 58308 
at 58309).
    Thus, the changes in the proposed rule would have benefited those 
companies wishing to export devices: (1) That have an approved U.S. 
IDE; (2) to countries that have agreed to accept U.S. IDE products; and 
(3) whose intended use is the same as the U.S. IDE. FDA believed this 
was as much

[[Page 954]]

relief as could be provided under existing law at the time.
    The agency received seven comments on the proposed rule. Most 
comments supported the rule, but recommended expanding the rule to 
explicitly mention certain devices (such as intraocular lenses and 
certain in vitro diagnostic devices), amending the rule so that a 
``CE'' mark would permit exportation of the device to any country, or 
amending the rule to consider marketing authorization by developed 
countries as permitting exportation to any country. One comment 
questioned the likelihood that a country would agree to the importation 
of all devices having approved IDE's.

II. The Export Act of 1996 and Its Impact on the Proposed Rule

    On April 26, 1996, the President signed the Export Act of 1996 
(Pub. L. 104-134, and later amended by Pub. L. 104-180). 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 could occur only if the 
agency has determined 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.
    Another provision of the Export Act of 1996 pertains specifically 
to drugs and devices exported for investigational use. Section 802(c) 
of the act states that a drug or device intended for investigational 
use in any country described in section 802(b)(1)(A)(i) and 
(b)(1)(A)(ii) of the act may be exported in accordance with the laws of 
that country and shall be exempt from regulation under sections 505(i) 
and 520(g) of the act (21 U.S.C. 355(i) and 360j(g)). Thus, under 
section 802(c) of the act, as amended, a device may be exported for 
investigational use to any of the listed countries without prior FDA 
approval and without compliance with the IDE regulations in part 812.
    However, 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 
(CGMP) 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), (a)(2)(A), (a)(3), and (c) of 
the act (21 U.S.C. 351(a)(1), (a)(2)(A), (a)(3), and (c)); and must 
comply with section 801(e)(1)(A) through (e)(1)(D) of the act, which 
require the device to be intended for export, 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 Export Act of 1996 affects the proposed rule in several ways. 
First, it accomplished some changes to the proposed rule that the 
comments requested, particularly those comments that requested that FDA 
expand the proposed rule to cover other devices and other FDA-regulated 
products or requested FDA to permit exportation to any country if a 
device received marketing authorization in the EU or marketing 
authorization in a ``developed country.'' Second, the Export Act of 
1996 also distinguishes between exports under section 801(e) of the act 
and exports under section 802 of the act. For example, when FDA 
published the proposed rule on November 27, 1995, devices were subject 
only to the requirements in section 801(e) of the act. The Export Act 
of 1996 gives firms an option whether to export a device under section 
801(e) of the act or under section 802 of the act, and assigned 
different requirements to exports under each section of the act. Thus, 
any final rule on device exports that FDA publishes would have to 
reflect these changes in the law.
    Finally, as stated earlier in this document, section 802(b)(1)(A) 
of the act authorizes export of an unapproved device to any country if 
the device complies with the laws of the importing country and the 
device has a valid marketing approval in any of the 25 countries 
identified in the act. Devices exported under section 802(b)(1)(A) of 
the act are also not required to obtain prior FDA approval, although 
they are subject to certain notification requirements, nor are they 
required to have an IDE. In contrast, the proposed rule's reference to 
exports of investigational devices for marketing purposes is limited to 
devices exported under section 801(e)(1) of the act and presumes that 
the person exporting the device has an IDE or is considered to have an 
approved IDE; thus, at a minimum, the proposed rule would have to be 
changed to reflect the requirements in section 802(b)(1)(A) of the act.
    Section 802(c) of the act also has a significant impact on the 
proposed rule. Under section 802(c) of the act, devices exported for 
investigational use to any listed country are not subject to the IDE 
requirements and can be exported without prior FDA approval. In 
comparison, the proposed rule would have required the exported device 
to have an approved IDE or to be a nonsignificant risk device and be 
considered to have an approved IDE, and the streamlined requirements 
described in the proposal would have applied only to exports to 
countries that had notified FDA of their willingness to accept IDE 
devices.
    The Export Act of 1996 contains other provisions that affect device 
exports. For example, devices exported under section 801(e) of the act 
do not have to comply with CGMP's, but devices exported under section 
802 of the act must be in ``substantial conformity'' with CGMP's or 
meet international standards as certified by an international standards 
organization recognized by the agency. Devices exported under section 
801(e) of the act must: (1) Accord to the foreign purchaser's 
specifications; (2) not conflict with the laws of the foreign country; 
(3) be labeled on the outside of the shipping package that the device 
is intended for export; and (4) not be offered for sale in the United 
States. In contrast, the labeling for devices exported under section 
802 of the act must, in addition to the requirements in section 
801(e)(1) of the act, be in accordance with the requirements and 
conditions of use of the listed country that authorized its marketing 
as well as the requirements and conditions of use

[[Page 955]]

in the foreign country that will receive the device. The labeling for 
devices exported under section 802 of the act also must be in the 
language and units of measurement of the foreign country or in the 
language designated by that country.

III. Issues for Public Comment

    Considering these changes in the export authority for devices, FDA 
is reopening for 60 days the comment period for the proposed rule. FDA 
is soliciting public comment on the following issues:
    1. Is a final rule still necessary? Given that section 802 of the 
act now provides additional flexibility for device exports and to 
export devices without the need to make export requests under section 
801(e)(2) of the act, is there still a need to streamline the export 
procedure under section 801(e)(2) of the act? If so, what specific 
relief for exports under Sec. 801(e)(2) of the act is sought for U.S. 
IDE devices that is not preceded by the new legislation?
    2. If a final rule is still necessary, what changes to the rule 
should be made? For example, the proposed rule included a program 
option under which foreign countries would notify FDA of their 
willingness to accept devices that are the subject of an approved IDE. 
However, there is little evidence to suggest that foreign governments 
will be willing to accept all IDE devices. Conceivably, a foreign 
government might be inclined to impose conditions on its acceptance of 
IDE devices, or accept some, but not all, devices. What are some 
alternatives to this program option? FDA invites interested persons to 
submit draft language for any suggested regulatory change.
    Interested persons may, on or before March 10, 1997 submit to the 
Dockets Management Branch (address above) written comments regarding 
this proposal. Two copies of any comments are to be submitted, except 
that individuals may submit one copy. Comments are to be identified 
with the docket number found in brackets in the heading of this 
document. Received comments may be seen in the office above between 9 
a.m. and 4 p.m., Monday through Friday.
    During this comment period and FDA's review of the comments, FDA 
will issue export permits under section 801(e)(2) of the act using 
current CDRH procedures. A copy of the procedures may be obtained 
through the Information Processing and Office Automation Branch (HFZ-
307), Division of Program Operations, CDRH, by calling 301-594-4520 or 
by faxing a request to 301-594-4528. In the event that FDA decides, 
after considering the comments received, not to issue a final rule or 
to issue a new proposal, FDA will continue to issue export permits 
under section 801(e)(2) of the act using current CDRH procedures.

    Dated: December 31, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-292 Filed 1-6-97; 8:45 am]
BILLING CODE 4160-01-F