Export Requirements for Medical Devices; Withdrawal of Proposed Rule

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.

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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

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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]

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