[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]



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

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.

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

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.
---------------------------------------------------------------------------

    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]
BILLING CODE 4160-01-F