[Federal Register Volume 60, Number 227 (Monday, November 27, 1995)]
[Proposed Rules]
[Pages 58308-58311]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-28894]
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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
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
its regulations for investigational devices to streamline requirements
for persons seeking to export unapproved medical devices. The proposed
rule would establish that FDA approval of an investigational device
exemption application (IDE) constitutes an agency determination that
the export of the unapproved device is not contrary to the public
health or safety. The proposed rule would also consider a country as
approving importation of an unapproved device if the country has
notified FDA that it approves of the importation of unapproved devices
with an approved IDE into their countries. Thus, for devices with an
FDA-approved IDE, the proposal would eliminate the need for FDA to make
independent determinations either that exportation is not contrary to
the public health or safety or that an importing country approves the
importation of a specific device. The proposed rule is intended to
codify and to simplify export requirements for certain unapproved
devices pursuant to the President's and Vice-President's ``National
Performance Review,'' as reflected in the April 1995 report titled,
``Reinventing Drug & Medical Device Regulations.'' The agency is also
requesting comments on other ways of improving the export process for
medical devices.
DATES: Written comments by February 12, 1996.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, Rm. 1-23, 12420 Parklawn Dr.,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Philip L. Chao, Office of Policy (HF-
23), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-827-3380.
SUPPLEMENTARY INFORMATION:
I. Introduction
Section 801(e)(1) (21 U.S.C. 381(e)(1)) of the Federal Food, Drug,
and Cosmetic Act (the act) states, in part, that a device intended for
export shall not be deemed to be adulterated or misbranded if it: (1)
meets the specifications of the foreign purchaser; (2) is not in
conflict with the laws of the country to which it is intended for
export; (3) is labeled on the outside of the shipping package that it
is intended for export; and (4) is not sold or offered for sale in
domestic commerce. Section 801(e)(1) of the act does not apply,
however, to any device that does not comply with an applicable
requirement under sections 514 (21 U.S.C. 360d) (performance standards)
or 515 (21 U.S.C. 360e) (premarket approval) of the act, a device
which, under section 520(g) of the act (21 U.S.C. 360j(g)), is exempt
from sections 514 and 515 of the act, or to a banned device, unless, in
addition to the requirements in section 801(e)(1), 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.'' (See section 801(e)(2) of the act.) This
statutory scheme requires parties to submit requests to FDA for
exportation of certain unapproved devices and also requires FDA to
approve such requests if the requirements in section 801(e) of the act
are met.
To enable FDA to determine whether the exportation of a particular
device is not contrary to the public health or safety, FDA generally
asks that the person seeking to export the device submit, along with
the export request, information or data regarding the device's safety.
However, if the device is the subject of an IDE approved by FDA and
will be marketed or used in clinical trials for the same intended use
in the foreign country, FDA does not require submission of safety data
with the export request because those safety data are already contained
in the IDE.
To determine whether a foreign country has approved importation of
a
[[Page 58309]]
device, a person who intends to export an unapproved device usually
provides FDA a letter from a foreign government official stating that
the foreign government does not object to the importation of the
device. The letter must identify the device and its intended use and
state that the device is not in conflict with the laws of the foreign
country (or that there is no objection to importation of the device),
that the foreign government has full knowledge of the device's
regulatory status in the United States, and that importation is
permitted. FDA has recently stated that, for devices with a ``CE'' mark
from the European Union, an additional letter from any importing
country within the European Economic Area would not be needed.
Each year, FDA receives hundreds of requests for permission to
export unapproved devices. In 1992, FDA handled 695 requests, and each
request required an average of 91 days to process. In 1993, FDA
processed 501 requests, but improved its average processing time to 65
days. In 1994, the agency processed 635 requests, and improved its
average processing time significantly further, to 16 days. From January
to September, 1995, the agency processed over 570 requests with an
average processing time of 10 days.
Yet, even though the average processing time for export requests
has significantly improved in recent years, FDA is aware that the
domestic industry continues to believe that the agency's export
approval obligations may affect a firm's ability to compete in
international markets and may represent an unnecessary regulatory
barrier. Consequently, in April 1995, FDA, as part of the President's
and Vice-President's ``National Performance Review,'' announced that it
would propose two new means by which unapproved devices could be
exported. First, the agency proposed permitting the export of
unapproved devices to certain advanced industrialized countries without
prior FDA review and approval, provided that the device complies with
the importing country's laws. FDA would seek the necessary legislative
changes and would consult Congress on the list of advanced
industrialized countries. In August, 1995, the Senate Committee on
Labor and Human Resources unanimously reported a bill (S. 593, as
amended) that would simplify export requirements for devices. If such
legislation is enacted, the agency will amend this rule if necessary.
Second, the National Performance Review 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.''
This proposed rule would implement the second half of the
Administration's initiative on reinventing device exports and is the
part of the initiative that FDA can achieve under current law. The
proposal would simplify and streamline the agency's export approval
process for certain unapproved devices. The agency requests comments on
other ideas for improving the export process for medical devices.
II. Description of the Proposed Rule
Currently, the only FDA regulation on device exports,
Sec. 812.18(b), states that, ``A person exporting an investigational
device subject to [part 812] shall obtain FDA's prior approval as
required by section 801(d) [sic] of the act.'' \1\ The proposed rule
would amend Sec. 812.18(b) to state that a person that wishes to export
an investigational device subject to part 812 must comply with the
requirements at section 801(e)(1) of the act, and proposed
Sec. 812.18(b)(1) would state that, for purposes of section 801(e)(2)
of the act, prior FDA approval is unnecessary if the investigational
device to be exported is the subject of an IDE approved by FDA 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 FDA-
approved IDE's.'' However, if the device is the subject of an FDA-
approved IDE and has received a ``CE'' mark from the European Union,
the device may be exported to any country in the European Economic
Area. Proposed Sec. 812.18(b)(1) would also state that the agency would
make available a list of countries that have approved the importation
of investigational devices that are the subjects of IDE's approved by
FDA. The agency expects to maintain this list electronically in the
Center for Devices and Radiological Health through the electronic
docket administered by the Center's Division of Small Manufacturer's
Assistance.
\1\ When FDA originally issued 21 CFR Sec. 812.18(b), the export
authority for devices was at section 801(d) of the act. However,
Congress renumbered the export provision as section 801(e) of the
act when it added a new section 801(d) as part of the Prescription
Drug Marketing Act of 1987. Thus, Sec. 812.18(b) contains an
obsolete reference to section 801(d) of the act, and the proposed
rule would correct this error.
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Under Sec. 812.2(b)(1), a nonsignificant risk (NSR) device is
considered to have an approved IDE as long as the sponsor complies with
the requirements of Sec. 812.2(b)(1)(i) through (vii). Therefore, the
streamlined requirements set forth in proposed Sec. 812.18(b)(1) also
would apply to NSR devices that comply with Sec. 812.2(b)(1).
Proposed Sec. 812.18(b)(2) would require FDA approval to export an
investigational device if FDA withdraws approval of the IDE (under
Sec. 812.30(b)) or the sponsor terminates any or all parts of
investigations because unanticipated adverse device effects present an
unreasonable risk to subjects (under Sec. 812.46(b)). FDA approval to
export an investigational device in these situations is required under
section 801(e)(2) of the act.
III. Legal Authority
As noted earlier, section 801(e)(2) of the act prohibits the export
of certain unapproved devices and banned medical devices unless FDA
determines that exportation of the device: (1) Is not contrary to the
public health or safety; and (2) has the approval of the country to
which it is intended for export. This section was added to the act as
part of the Medical Device Amendments of 1976 (Pub. L. 94-295) and the
legislative history for the Medical Device Amendments indicates that
Congress considered two distinct export provisions. One provision
suggested by the House of Representatives would have permitted export
of an unapproved device to any foreign country that had an
``appropriate'' health agency where such agency had reviewed and
approved the device. FDA would receive notice of the export, but would
not be required to approve exportation. In contrast, the Senate
provision would have authorized export of unapproved devices if FDA
determined that exportation ``was in the interest of public health and
safety'' and the device had the approval of the country to which it was
being exported. Thus, unlike the House provision, the Senate provision
would have required the agency to make certain determinations before
the device could be exported. Congress ultimately enacted a provision
that was very similar to the Senate version.
The proposed rule is consistent with the legislative history and
section 801(e)(2) of the act. FDA would still determine whether
exportation of the device was contrary to the public health
[[Page 58310]]
or safety and whether the foreign country receiving the device approves
of the device's importation. The principal difference between the
current device export approval process and the proposed rule is that,
under the proposed rule, FDA would consider the existence of an FDA-
approved IDE to be FDA's determination that exportation of the device
is not contrary to the public health or safety. Additionally, the list
of countries that FDA would maintain would represent the agency's
determination that, for those countries on the list, the country
approves of the importation of investigational devices. By making these
determinations in advance, through the IDE process and the list of
countries, no separate export approval would be required, and so the
device export process would be much simplified and streamlined.
Courts have routinely upheld similar ``blanket'' determinations or
findings made by administrative agencies. For example, in Weinberger v.
Hynson, Westcott and Dunning, Inc., 412 U.S. 609 (1973), the Supreme
Court examined, among other things, whether FDA was required to conduct
individual hearings for each manufacturer of similar drug products
before it could withdraw those drug products from the market. The Court
declined to require individual hearings because ``many hearings would
be an exercise in futility'' and ``To require separate judicial
proceedings to be brought against each * * * would be to create delay
where in the interest of public health there should be prompt action.''
(Id. at pp. 621, 624-625.)
Similarly, in In re Permian Basin Area Rate Cases, 390 U.S. 747
(1968), the Supreme Court declined to require an agency to engage in
individual proceedings, upholding the agency's ability to use a
comprehensive and practical regulatory approach. The Court recognized
that, ``[C]onsiderations of flexibility and practicality are certainly
germane to the issues before us * * * We cannot, in these
circumstances, conclude that Congress has given authority inadequate to
achieve with reasonable effectiveness the purpose for which it acted.''
(Id. at p. 777 (citations omitted).) (See also Phillips Petroleum
Company v. U.S. Environmental Protection Agency, 803 F.2d 545, 562
(10th Cir. 1986) (The Environmental Protection Agency was ``well within
its discretion to use a generic streamlined approach or procedure''
instead of case-by-case determinations as to the necessity of a
mechanical integrity test).)
This proposed rule is consistent with these court decisions because
FDA is making its determination that an approved IDE provides a
satisfactory basis for its required determination that exportation of a
device is not contrary to public health or safety. The agency is making
this determination through this rulemaking, providing an opportunity
for comment to all interested persons. Assuming that the agency issues
a final rule, there will be no need for the agency to make case-by-case
determinations that such devices do not present a public health or
safety concern. Similarly, the need to make an individual determination
that a foreign country has approved the device's importation is
eliminated where such country has already indicated that it will permit
the importation of all FDA-approved IDE devices. Requiring the
submission and FDA review of the same information that the agency
already has, in these cases, would unnecessarily consume agency and
industry resources and delay exportation.
The proposed rule, therefore, is authorized by sections 520(g) and
801(e)(2) of the act and the general rulemaking authority under section
701(a) of the act and is consistent with judicial decisions upholding
an agency's authority to develop streamlined, efficient procedures to
make determinations applicable to a group or class of persons or
products, rather than proceeding on a case-by-case basis.
IV. Analysis of Impacts
FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).
Executive Order 12866 directs agencies to assess all costs and benefits
of available regulatory alternatives and, when regulation is necessary,
to select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this proposed rule is consistent with the regulatory philosophy and
principles identified in the Executive Order. This proposed rule meets
the definition of a significant regulatory action in the Executive
Order in that it raises novel legal and policy issues arising from
Presidential priorities, and so has been reviewed by OMB under the
Executive Order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because the proposed rule, if finalized, would
simplify and lessen regulatory burdens on persons seeking to export
unapproved devices that are the subjects of approved IDE's and that are
to be exported to a country that has given a blanket approval to
importation of devices that are the subjects of FDA-approved IDE's, the
agency certifies that the proposed rule would not impose any additional
regulatory burdens on small entities, and so, under the Regulatory
Flexibility Act, no further analysis is required.
V. Environmental Impact
The agency has determined, under 21 CFR Sec. 25.24(a)(8), that this
action is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
Interested persons may, on or before February 12, 1996, 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.
VI. Paperwork Reduction Act of 1995
This proposed rule would simplify and streamline the device export
process, and does not impose any new information collection
requirements. The existing information collection requirements in 21
CFR part 812 have been approved under OMB control no. 0910-0078 which
expires on May 31, 1996.
List of Subjects
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
the authority delegated to the Commissioner of Food and Drugs, it is
proposed that Title 21 of the Code of Federal Regulations be amended as
follows:
PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS
1. The authority citation for 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, 903 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, 393); secs.
215, 301, 351, 352, 353-360F of the Public
[[Page 58311]]
Health Service Act (42 U.S.C. 216, 241, 262, 263, 263a-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 comply with section 801(e)(1) of the act, and shall
obtain FDA's prior approval, as required by section
801(e)(2) of the act. However, if the investigational device to be
exported is the subject of an investigational device exemption
application (IDE) approved by FDA:
(1) No prior approval shall be necessary provided that the
investigational device to be exported 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 subjects of FDA-approved IDE's. (For devices that have
received a ``CE'' mark from the European Union, the valid granting of a
CE mark for a device that is the subject of an FDA-approved IDE shall
constitute approval of the device for importation into any country in
the European Economic Area.) A list of countries that have approved the
importation of investigational devices that are the subjects of IDE's
approved by FDA is available from the Center for Devices and
Radiological Health, Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857.
(2) If FDA withdraws approval of the IDE or the sponsor terminates
any or all parts of investigations because unanticipated adverse device
effects present an unreasonable risk to subjects, exportation of the
investigational device may continue only with FDA approval in
accordance with section 801(e)(2) of the act.
Dated: November 13, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-28894 Filed 11-24-95; 8:45 am]
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