Export Requirements for Medical Devices; Reopening of Comment Period

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