[Federal Register Volume 62, Number 109 (Friday, June 6, 1997)]
[Proposed Rules]
[Pages 31023-31025]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-14749]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 812

[Docket No. 95N-0342]


Export Requirements for Medical Devices; Withdrawal of Proposed 
Rule

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; withdrawal.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is withdrawing a 
proposed rule that appeared in the Federal Register of November 27, 
1995 (60 FR 58308). The proposed rule would have amended FDA's 
regulations for exporting devices for investigational use. FDA is 
withdrawing the proposed rule because recent statutory changes have 
made the rulemaking unnecessary.

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 
Federal Food, Drug, and Cosmetic Act (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 approval of certain exports of 
unapproved devices. The second provision, 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) (Export 
Act of 1996).
    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. FDA issued a 
proposed rule to simplify the agency's export approval process for 
certain unapproved devices (60 FR 58308). 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 initiative, 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.
    The report also 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.'' Consequently, FDA 
proposed to amend 21 CFR 812.18 to state that a person who wishes to 
export an investigational device subject to part 812 (21 CFR part 812) 
(investigational devices) must comply with the requirements at section 
801(e)(1) of the act, but that, for purposes of section 801(e)(2) of 
the act, 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).
    The proposed rule also would have FDA make available a list of 
countries that have approved the importation of investigational devices 
that are the subjects of approved IDE's. Additionally, the proposal 
would require prior FDA approval to export an

[[Page 31024]]

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).
    The agency received 7 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.
    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) or 
(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 section 
505(i) or 520(g)'' of the act. 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 at part 812.
     However, all devices exported under section 802 of the act are 
subject to certain requirements, under section 802(f) and (g) 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) or section 
501(c) of the act; and must comply with section 801(e)(1)(A) through 
(e)(1)(D) of the act (which requires the 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). 
Further, exporters must maintain records of products exported.
    The Export Act of 1996 affected 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 distinguished 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 gave 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.
    Finally, as stated earlier, 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 countries identified in the act. 
Devices exported under section 802(b)(1)(A) of the act are neither 
required to obtain prior FDA approval (although they are subject to 
certain notification and recordkeeping requirements) nor are they 
required to have an IDE. In contrast, the proposed rule's reference to 
exports of investigational devices for marketing purposes would have 
been limited to devices exported under section 801(e)(2) of the act and 
presumed that the person exporting the device has an IDE or is 
considered to have an approved IDE.
    Section 802(c) of the act, as revised by the Export Act of 1996, 
also had 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.
    Considering these changes in the export authority for devices and 
their effect on the proposed rule, FDA published a notice in the 
Federal Register on January 7, 1997 (62 FR 953) to reopen the comment 
period for the proposed rule and to solicit public comment on whether 
the proposed rule was still necessary. The agency received three 
comments in response to its notice, and all three comments agreed that 
the statutory changes eliminated the need for the proposed rule. FDA 
agrees with the comments, and, through this notice, is withdrawing the 
proposed rule that appeared in the Federal Register on November 27, 
1995.
    In the Federal Register of May 13, 1997 (62 FR 26228), the agency 
amended Sec. 812.18 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 statutory references. At this time the 
agency believes that no further amendment to these regulations is 
necessary.
    Therefore, under the Federal Food, Drug and Cosmetic Act (secs. 
301, 501,

[[Page 31025]]

502, 503, 505, 506, 507, 510, 513-516, 518-520, 701, 702, 704, 721, 
801, 802, and 803) and under 21 CFR 5.10, the proposed rule published 
in the Federal Register of November 27, 1995 (60 FR 58308), is 
withdrawn.

    Dated: May 29, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-14749 Filed 6-5-97; 8:45 am]
BILLING CODE 4160-01-F