63606 Federal Register / Vol. 60, No. 237 / Monday, December 11, 1995 / Rules and Regulations

(b) U.S.-designated agents of foreign

manufacturers are required to:

(1) Report to FDA in accordance with

§§ 803.50, 803.52, 803.53, 803.55, and

803.56;

(2) Conduct, or obtain from the

foreign manufacturer the necessary

information regarding, the investigation

and evaluation of the event to comport

with the requirements of § 803.50;

(3) Certify in accordance with

§ 803.57;

(4) Forward MDR complaints to the

foreign manufacturer and maintain

documentation of this requirement;

(5) Maintain complaint files in

accordance with § 803.18; and

(6) Register, list, and submit

premarket notifications in accordance

with part 807 of this chapter.

PART 807—ESTABLISHMENT

REGISTRATION AND DEVICE LISTING

FOR MANUFACTURERS AND

DISTRIBUTORS OF DEVICES

2. The authority citation for 21 CFR

part 807 continues to read as follows:

Authority: Secs. 301, 501, 502, 510, 513,

515, 519, 520, 701, 704 of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 331, 351,

352, 360, 360c, 360e, 360i, 360j, 371, 374).

3. Section 807.3 is amended by

adding new paragraph (r) to read as

follows:

§ 807.3 Definitions.

* * * * *

(r) U.S.-designated agent means the

person, residing in the United States,

designated and authorized by the owner

or operator of a foreign manufacturer

who exports devices into the United

States and is responsible for:

(1) Submitting MDR reports,

(2) Submitting annual certifications,

(3) Acting as the official

correspondent,

(4) Submitting registration

information,

(5) Submitting device listing

information, and

(6) Submitting premarket notifications

on behalf of the foreign manufacturer.

4. Section 807.20 is amended by

adding new paragraph (a)(6) to read as

follows:

§ 807.20 Who must register and submit a

device list.

(a) * * *

(6) Acts as the U.S.-designated agent

as defined in § 807.3(r).

* * * * *

5. Section 807.22 is amended by

revising paragraph (a) to read as follows:

§ 807.22 How and where to register

establishments and list devices.

(a) The first registration of a device

establishment shall be on Form FDA–

2891 (Initial Registration of Device

Establishment). Forms are available

upon request from the Office of

Compliance, Center for Devices and

Radiological Health (HFZ–307), Food

and Drug Administration, 2098 Gaither

Rd., Rockville, MD 20850, or from Food

and Drug Administration district offices.

Subsequent annual registration shall be

accomplished on Form FDD–2891a

(Annual Registration of Device

Establishment), which will be furnished

by FDA to establishments whose

registration for that year was validated

under § 807.35(a). The forms will be

mailed to the owner or operators of all

establishments via the official

correspondent in accordance with the

schedule as described in § 807.21(a).

The completed form shall be mailed to

the address designated in this paragraph

30 days after receipt from FDA.

* * * * *

6. Section 807.40 is revised to read as

follows:

§ 807.40 Establishment registration and

device listing for U.S. agents of foreign

manufacturers of devices.

(a) Each foreign device manufacturer

who exports devices into the United

States shall designate a person as their

U.S.-designated agent, who is

responsible for:

(1) Submitting MDR reports,

(2) Submitting annual certifications,

(3) Acting as the official

correspondent,

(4) Submitting registration

information,

(5) Submitting device listing

information, and

(6) Submitting premarket

notifications.

(b) The foreign manufacturer shall

provide FDA with a statement of

authorization for their U.S.-designate to

perform MDR reporting duties under

part 803 of this chapter, and to register,

list, and submit premarket notifications

under this part. The foreign

manufacturer must provide this

statement of authorization along with

the name, address, and telephone

number of the person initially

designated, or any subsequent person

designated as the U.S.-designated agent,

within 5 days of the initial or

subsequent designation. Information

shall be sent to the Center for Devices

and Radiological Health, Medical

Device Reporting, Food and Drug

Administration, P.O. Box 3002,

Rockville, MD 20847–3002.

(c) The U.S.-designated agent of a

foreign device manufacturer that exports

devices into the United States is

required to register the foreign

manufacturer’s establishments or places

of business, and to list the foreign

manufacturer’s devices, in accordance

with subpart B of this part, unless

exempt under subpart D of this part, and

to submit premarket notifications in

accordance with subpart E of this part.

The information submitted shall be in

the English language.

Dated: October 25, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–29906 Filed 12–8–95; 8:45 am]

BILLING CODE 4160–01–P

21 CFR Part 5

Delegations of Authority; Medical

Device Reporting Procedures

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

regulations for delegations of authority

to redelegate to certain officials in the

Center for Devices and Radiological

Health (CDRH) authorities relating to

medical device reporting procedures.

EFFECTIVE DATE: December 11, 1995.

FOR FURTHER INFORMATION CONTACT:

Kerry G. Rothschild, Center for

Devices and Radiological Health

(HFZ–84), Food and Drug

Administration, 2094 Gaither Rd.,

Rockville, MD 20850, 301–594–

4765, or

Ellen R. Rawlings, Division of

Management Systems and Policy

(HFA–340), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–

4976.

SUPPLEMENTARY INFORMATION: FDA is

amending the delegations of authority

under part 5 (21 CFR part 5) by adding

new § 5.98 Authority relating to medical

device reporting procedures. In

conjunction with CDRH’s issuance of a

medical device reporting final rule

under section 519 of the Federal Food,

Drug, and Cosmetic Act (the act) (21

U.S.C. 360i), the Commissioner of Food

and Drugs (the Commissioner) has

decided to delegate to certain officials in

CDRH the authority to approve

electronic reporting under 21 CFR

803.14, to request the submission of

additional information under 21 CFR

803.15, and to grant or revoke

exemptions and variances from

reporting requirements under 21 CFR

803.19. Delegation of these authorities

to the directors and deputy directors of

the Office of the Director and the Office

of Surveillance and Biometrics, CDRH,
Federal Register / Vol. 60, No. 237 / Monday, December 11, 1995 / Rules and Regulations 63607

will increase the efficiency of the

medical device reporting process.

The authority delegated may be

redelegated further only with the

Commissioner’s approval. Authority

delegated to a position by title may be

exercised by a person officially

designated to serve in such position in

an acting capacity or on a temporary

basis.

List of Subjects in 21 CFR part 5

Authority delegations (Government

agencies), Imports, Organization and

functions (Government agencies).

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 5 is

amended as follows:

PART 5—DELEGATIONS OF

AUTHORITY AND ORGANIZATION

1. The authority citation for 21 CFR

part 5 continues to read as follows:

Authority: 5 U.S.C. 504, 552, App. 2; 7

U.S.C. 138a, 2271; 15 U.S.C. 638, 1261–1282,

3701–3711a; secs. 2–12 of the Fair Packaging

and Labeling Act (15 U.S.C. 1451–1461); 21

U.S.C. 41–50, 61–63, 141–149, 467f, 679(b),

801–886, 1031–1309; secs. 201–903 of the

Federal Food, Drug, and Cosmetic Act (21

U.S.C. 321–394); 35 U.S.C. 156; secs. 301,

302, 303, 307, 310, 311, 351, 352, 354, 361,

362, 1701–1706, 2101, 2125, 2127, 2128 of

the Public Health Service Act (42 U.S.C. 241,

242, 242a, 242l, 242n, 243, 262, 263, 263b,

264, 265, 300u–300u–5, 300aa–1, 300aa–25,

300aa–27, 300aa–28); 42 U.S.C. 1395y,

3246b, 4332, 4831(a), 10007–10008; E.O.

11490, 11921, and 12591; secs. 312, 313, 314

of the National Childhood Vaccine Injury Act

of 1986, Pub. L. 99–660 (42 U.S.C. 300aa–1

note).

2. New § 5.98 is added to subpart B

to read as follows:

§ 5.98 Authority relating to medical device

reporting procedures.

(a) The Director and Deputy Directors,

Center for Devices and Radiological

Health (CDRH), and the Director and

Deputy Director, Office of Surveillance

and Biometrics, CDRH, are authorized to

approve electronic reporting under

§ 803.14 of this chapter.

(b) The Director and Deputy Directors,

Center for Devices and Radiological

Health (CDRH), and the Director and

Deputy Director, Office of Surveillance

and Biometrics, CDRH, are authorized to

request the submission of additional

information under § 803.15 of this

chapter.

(c) The Director and Deputy Directors,

Center for Devices and Radiological

Health (CDRH), and the Director and

Deputy Director, Office of Surveillance

and Biometrics, CDRH, are authorized to

grant or revoke exemptions and

variances from reporting requirements

under § 803.19 of this chapter.

Dated: September 1, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–29905 Filed 12–8–95; 8:45 am]

BILLING CODE 4160–01–F