[Federal Register Volume 62, Number 247 (Wednesday, December 24, 1997)]
[Rules and Regulations]
[Pages 67270-67273]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33482]



[[Page 67270]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 5


Delegations of Authority and Organization; Center for Devices and 
Radiological Health

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the 
regulations for delegations of authority relating to functions 
performed by the Center for Devices and Radiological Health (CDRH). 
This amendment updates the titles of CDRH delegates and organizational 
components to reflect the organizational restructuring and also 
publishes delegations of authority to additional positions within CDRH. 
This action is intended to ensure the accuracy and consistency of the 
regulations.

EFFECTIVE DATE: December 24, 1997.

FOR FURTHER INFORMATION CONTACT:
    Debra A. Baclawski, Center for Devices and Radiological Health 
(HFZ-026), Food and Drug Administration, 1350 Piccard Dr., Rockville, 
MD 20850, 301- 443-1060, or
    Donna G. Page, Division of Management Systems and Policy (HFA-340), 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 
301-827-4816.

SUPPLEMENTARY INFORMATION: CDRH has undergone an organizational 
restructuring (58 FR 35959, July 2, 1993), which was approved by the 
Commissioner of Food and Drugs. The authorities delegated to the CDRH 
officials are amended in this document to reflect new titles and 
organization placement under the restructuring and also it publishes 
delegations of authority to additional positions within the center.
    The most significant changes are: (1) The establishment of a second 
Deputy Director in the Office of the Director, CDRH, and in the Office 
of Device Evaluation; (2) the reorganization and retitling of the 
Office of Compliance and Surveillance to the Office of Compliance; and 
(3) the redelegation of authority to each of the Division Directors in 
the Office of Compliance.
    Further redelegation of the authorities delegated is not authorized 
at this time. Authority delegated to a position 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; 15 U.S.C. 1451-1461; 21 U.S.C. 
41-50, 61-63, 141-149, 321-394, 467f, 679(b), 801-886, 1031-1309; 35 
U.S.C. 156; 42 U.S.C. 241, 242, 242a, 242l, 242n, 243, 262, 263, 
264, 265, 300u-300u-5, 300aa-1; 1395y, 3246b, 4332, 4831(a), 10007-
10008; E.O. 11921, 41 FR 24294, 3 CFR, 1977 Comp., p. 124-131; E.O. 
12591, 52 FR 13414, 3 CFR, 1988 Comp., p. 220-223
    2. Section 5.22 is amended by revising paragraphs (a)(10)(i), 
(a)(10)(ii), (a)(10)(iv), and (a)(10)(v) to read as follows:

Sec. 5.22  Certification of true copies and use of Department seal.

    (a) *   *   *
    (10)(i) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH).
    (ii) The Associate Director and Deputy Associate Director for 
Management and Systems, CDRH.
* * * * *
    (iv) For medical devices assigned to their respective divisions, 
the Division Directors, Office of Compliance, CDRH.
    (v) Freedom of Information Officers, CDRH.
*     *     *     *     *
    3. Section 5.23 is amended by revising paragraphs (c)(1) through 
(c)(4) to read as follows:

Sec.  5.23  Disclosure of official records.

*     *     *     *     *
    (c) *   *   *
    (1) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH).
    (2) The Director and Deputy Director, Office of Compliance, CDRH.
    (3) The Director and Deputy, Division of Program Operations, Office 
of Compliance, CDRH.
    (4) The Chief, Information Processing and Automation Branch, 
Division of Program Operations, Office of Compliance, CDRH.
*     *     *     *     *
    4. Section 5.25 is amended by revising paragraphs (a)(2) and (b) to 
read as follows:

Sec. 5.25  Research, investigation, and testing programs and health 
information and health promotion programs.

    (a) *   *   *
    (2) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH).
*     *     *     *    *
    (b) The Director and Deputy Directors, CDRH, are authorized to 
establish an electronic product radiation control program and to 
approve grants for conducting the program under section 356 of the act.
*     *     *     *     *
    5. Section 5.26 is amended by revising paragraph (c) to read as 
follows:

Sec. 5.26  Service fellowships.

*     *     *     *     *
    (c) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH), and the Director, Office of Systems and 
Management, CDRH.
*     *     *     *     *
    6. Section 5.28 is revised to read as follows:

Sec. 5.28  Cardiac pacemaker devices and pacemaker leads.

    The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH), are authorized to perform all the functions 
of the Commissioner of Food and Drugs with regard to a registry of all 
cardiac pacemaker devices and pacemaker leads for which payment was 
made under the Social Security Act (42 U.S.C. 1395y(h)(l),(2)(A), and 
(3)), as amended.
    7. Section 5.30 is amended by revising paragraphs (b) and (c)(4) to 
read as follows:

Sec. 5.30  Hearings.

*     *     *     *     *
    (b) The Director and Deputy Directors, CDRH, are authorized to hold 
hearings, and to designate other officials to hold informal hearings, 
under section 360(a) of the Public Health Service Act.
    (c) *   *  *
    (4) The Director and Deputy Directors, CDRH.
*     *     *     *     *
    8. Section 5.31 is amended by revising paragraphs (c)(3) and (e)(5) 
to read as follows:


[[Page 67271]]




Sec. 5.31  Petitions under part 10.

*     *     *     *     *
    (c) *   *   *
    (3) The Director and Deputy Directors, Center for Devices and 
Radiological Health.
*     *     *     *     *
    (e) *   *   *
    (5) The Director and Deputy Directors, CDRH, are authorized to 
issue 180-day tentative responses to citizen petitions on medical 
device matters under Sec. 10.30(e)(2)(iii) of this chapter that relate 
to the assigned functions of that Center.
*     *     *     *     *
    9. Section 5.33 is amended by revising paragraph (b) to read as 
follows:

Sec. 5.33  Premarket approval of a product that is or contains a 
biologic, a device, or a drug.

*     *     *     *     *
    (b) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH), and the Director, Office of Device 
Evaluation, CDRH.
    *     *     *     *     *
    10. Section 5.37 is amended by revising paragraphs (a)(2)(i) 
through (a)(2)(iii) and (b)(1) through (b)(3), and by removing 
paragraph (a)(2)(iv) and removing and reserving (b)(4) to read as 
follows:

Sec. 5.37  Issuance of reports of minor violations.

    (a) *  *   *
    (2)(i) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH).
    (ii) The Director and Deputy Director, Office of Compliance, CDRH.
    (iii) For medical devices assigned to their respective divisions, 
the Division Directors, Office of Compliance, CDRH.
* * * * *
    (b) *   *   *
    (1) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH).
    (2) The Director and Deputy Director, Office of Compliance, CDRH.
    (3) For medical devices assigned to their respective divisions, the 
Division Directors, Office of Compliance, CDRH.
*     *     *     *     *
    11. Section 5.45 is amended by revising paragraphs (b) introductory 
text, (c)(1) and (c)(2), and (e)(1)(i) through (e)(1)(iii) to read as 
follows:

Sec. 5.45  Imports and exports.

*     *     *     *     *
    (b) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH); the Director and Deputy Director, Office of 
Compliance, CDRH; Regional Food and Drug Directors; District Directors; 
and the Director, St. Louis Branch, are authorized, under section 360 
of the Public Health Service Act (PHSA), to perform the following 
functions or to designate officials to:
* * * * *
    (c) *   *   *
    (1) The Director and Deputy Directors, CDRH.
    (2) The Director and Deputy Director, Office of Compliance, CDRH.
*     *     *     *     *
    (e) *   *   *
    (1) *   *   *
    (i) The Director and Deputy Directors, CDRH.
    (ii) The Director and Deputy Director, Office of Compliance, CDRH.
    (iii) The Director and Deputy Director, Division of Program 
Operations, Office of Compliance, CDRH.
*     *     *     *     *
    12. Section 5.46 is revised to read as follows:

Sec. 5.46  Manufacturer's resident import agents.

    The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH) and the Director and Deputy Director, Office 
of Compliance, CDRH, are authorized to reject manufacturer's 
designation of import agents under Sec. 1005.25(b) of this chapter.
    13. Section 5.47 is amended by revising paragraphs (a)(1) and 
(a)(2) to read as follows:

Sec. 5.47  Detention of adulterated or misbranded medical devices.

*     *     *     *     *
    (a) *   *   *
    (1) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH).
    (2) The Director and Deputy Director, Office of Compliance, CDRH.
*     *     *     *     *
    14. Section 5.49 is amended by revising paragraph (a) to read as 
follows:

Sec. 5.49  Authorization to use alternative evidence for determination 
of the effectiveness of medical devices.

*     *     *     *     *
    (a) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH), and the Director and Deputy Directors, 
Office of Device Evaluation, CDRH.
*      *     *     *     *
    15. Section 5.50 is amended by revising paragraph (a) to read as 
follows:

Sec. 5.50  Notification to petitioners of determinations made on 
petitions for reclassification of medical devices.

*     *     *     *     *
    (a) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH) and the Director and Deputy Directors, 
Office of Device Evaluation.
*     *     *     *     *
    16. Section 5.51 is amended by revising paragraphs (a)(1) and 
(b)(1) to read as follows:

Sec. 5.51  Determination of classification of devices.

    (a) *   *   *
    (1) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH) and the Director and Deputy Directors, 
Office of Device Evaluation, CDRH.
*     *     *     *     *
    (b) *   *   *
    (1) The Director and Deputy Directors, CDRH, and the Director, 
Deputy Directors, Chief of the Premarket Notification Section, Division 
and Deputy Division Directors, Associate Division Directors, and Branch 
Chiefs, Office of Device Evaluation, CDRH.
*     *     *     *     *
    17. Section 5.52 is amended by revising paragraph (a) to read as 
follows:

Sec. 5.52  Notification to sponsors of deficiencies in petitions for 
reclassification of medical devices.

*     *     *     *     *
    (a) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH) and the Director and Deputy Directors, 
Office of Device Evaluation, CDRH.
*     *     *     *     *
    18. Section 5.53 is amended by revising paragraphs (a)(1), 
(b)(1)(i), and (c) to read as follows:

Sec. 5.53  Approval, disapproval, or withdrawal of approval of product 
development protocols and applications for premarket approval for 
medical devices.

    (a) *   *   *
    (1) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH), and the Director and Deputy Directors, 
Office of Device Evaluation, CDRH.
*     *     *     *     *
    (b)(1) *   *   *
    (i) The Director and Deputy Directors, CDRH, and the Director and 
Deputy Directors, Office of Device Evaluation, CDRH.
*     *     *     *     *
    (c) The Director and Deputy Directors, CDRH, for medical devices 
assigned to

[[Page 67272]]

their organization, are authorized to issue notices to announce the 
approval, disapproval, or withdrawal of approval of a device, and to 
make publicly available a detailed summary of the information on which 
the decision was based, under sections 515(d), (e), and (g) and 
520(h)(1) of the act.
    19. Section 5.54 is amended by revising paragraph (a) to read as 
follows:

Sec. 5.54  Determinations that medical devices present unreasonable 
risk of substantial harm.

*     *     *     *     *
    (a) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH), and the Director and Deputy Director, 
Office of Compliance, CDRH.
*     *     *     *     *
    20. Section 5.55 is amended by revising paragraph (a) to read as 
follows:

Sec. 5.55  Orders to repair or replace, or make refunds for, medical 
devices.

*     *     *     *     *
    (a) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH), and the Director and Deputy Director, 
Office of Compliance, CDRH.
*     *     *     *     *
    21. Section 5.56 is amended by revising paragraphs (a) and (b) to 
read as follows:

Sec. 5.56  Recall authority.

*     *     *     *     *
    (a) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH).
    (b) The Director and Deputy Director, Office of Compliance, CDRH.
*     *     *     *     *
    22.  Section 5.57 is amended by revising paragraphs (a) through (c) 
to read as follows:

Sec. 5.57  Temporary suspension of a medical device application.

*     *     *     *     *
    (a) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH).
    (b) The Director and Deputy Director, Office of Compliance, CDRH.
    (c) The Director and Deputy Directors, Office of Device Evaluation, 
CDRH.
*     *     *     *     *
    23. Section 5.59 is amended by revising paragraph (a)(1) to read as 
follows:

Sec. 5.59  Approval, disapproval, or withdrawal of approval of 
applications for investigational device exemptions.

    (a)  *   *   *
    (1) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH), the Director and Deputy Directors, Office 
of Device Evaluation, CDRH, and the Director and Deputy Director, 
Office of Compliance, CDRH.
*     *     *     *     *
    24. Section 5.60 is amended by revising paragraphs (a)(1) through 
(a)(4), (a)(6), and (b)(1) through (b)(5) to read as follows:


Sec. 5.60  Required and discretionary postmarket surveillance.

    (a) *   *   *
    (1) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH).
    (2) The Director and Deputy Director, Office of Surveillance and 
Biometrics, CDRH.
    (3) The Director and Deputy Director, Division of Postmarket 
Surveillance, Office of Surveillance and Biometrics, CDRH.
    (4) The Director and Deputy Directors, Division Directors and 
Associate Division Directors, Office of Device Evaluation, CDRH.
* * * * *
    (6) The Director and Deputy Director, Office of Compliance, CDRH.
*     *     *     *     *
    (b) *   *   *
    (1) The Director and Deputy Directors, CDRH.
    (2) The Director and Deputy Director, Office of Surveillance and 
Biometrics, CDRH.
    (3) The Director and Deputy Director, Division of Postmarket 
Surveillance, Office of Surveillance and Biometrics, CDRH.
    (4) The Director and Deputy Directors, Office of Device Evaluation, 
CDRH.
    (5) The Director and Deputy Director, Office of Compliance, CDRH.
*     *     *     *     *
    25. Section 5.78 is amended by revising paragraph (b) to read as 
follows:

Sec. 5.78  Issuance, amendment, or repeal of regulations pertaining to 
antibiotic drugs.

*     *     *     *     *
    (b) The Director and Deputy Directors, Center for Devices and 
Radiological Health, are authorized to perform all the functions of the 
Commissioner of Food and Drugs under section 507 of the act regarding 
the issuance, amendment, or repeal of regulations pertaining to 
antibiotic drugs for human use contained in medical devices.
    26. Section 5.86 is amended by revising paragraphs (a) and (b), and 
by removing paragraph (c) to read as follows:


Sec. 5.86  Variances from performance standards for electronic 
products.

*     *     *     *     *
    (a) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH).
    (b) The Director and Deputy Director, Office of Compliance, CDRH.
    27. Section 5.87 is amended by revising paragraphs (a) and (b), and 
by removing paragraph (c) to read as follows:

Sec. 5.87  Exemption of electronic products from performance standards 
and prohibited acts.

*     *     *     *     *
    (a) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH).
    (b) The Director and Deputy Director, Office of Compliance, CDRH.
    28. Section 5.88 is revised to read as follows:

Sec. 5.88  Testing programs and methods of certification and 
identification for electronic products.

    The Director and Deputy Directors, Center for Devices and 
Radiological Health, (CDRH), and the Director and Deputy Director, 
Office of Compliance, CDRH, are authorized to review and evaluate 
industry testing programs under section 358(g) of the Public Health 
Service Act (the act), and to approve or disapprove alternate methods 
of certification and identification and to disapprove testing programs 
upon which certification is based under section 358(h) of the act.
    29. Section 5.89 is amended by revising paragraphs (a) introductory 
text and (b) introductory text to read as follows:

Sec. 5.89  Notification of defects in, and repair or replacement of, 
electronic products.

    (a) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH), and the Director and Deputy Director, 
Office of Compliance, CDRH, are authorized to perform all functions of 
the Commissioner of Food and Drugs, relating to notification of defects 
in, noncompliance of, and repair or replacement of or refund for, 
electronic products under section 359 of the Public Health Service Act 
(the act) and under Secs. 1003.11, 1003.22, 1003.31, 1004.2, 1004.3, 
1004.4, and 1004.6 of this chapter; and Regional Food and Drug 
Directors, District Directors, and the Director, St. Louis Branch, are 
authorized to perform all such functions relating to:
*     *     *     *     *
    (b) The Director and Deputy Director, Office of Compliance, CDRH, 
and the

[[Page 67273]]

Division Directors, Office of Compliance, CDRH, are authorized to 
notify manufacturers of defects in, and noncompliance of, electronic 
products under section 359(e) of the act and under Sec. 1003.11(a) of 
this chapter; and the chiefs of District Compliance Branches are 
authorized to perform all such functions relating to:
*     *     *     *     *
    30. Section 5.90 is revised to read as follows:

Sec. 5.90  Manufacturers requirement to provide data to ultimate 
purchasers of electronic products.

    The Director and Deputy Directors, Center for Devices and 
Radiological Health, are authorized to require manufacturers to provide 
performance and technical data to the ultimate purchaser of electronic 
products under section 360A(c) of the Public Health Service Act.
    31. Section 5.91 is revised to read as follows:

Sec. 5.91  Dealer and distributor direction to provide data to 
manufacturers of electronic products.

    The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH), the Director and Deputy Director, Office of 
Compliance, CDRH, and the Division Directors, Office of Compliance, 
CDRH, are authorized to direct dealers and distributors of electronic 
products to furnish information on first purchasers of such products to 
the manufacturer of the product under section 360A(f) of the Public 
Health Service Act.
    32. Section 5.92 is revised to read as follows:

Sec. 5.92  Acceptance of assistance from State and local authorities 
for enforcement of radiation control legislation and regulations.

    The Director and Deputy Directors, Center for Devices and 
Radiological Health, are authorized to accept assistance from State and 
local authorities engaged in activities related to health or safety or 
consumer protection on a reimbursable basis or otherwise, under section 
360E of the Public Health Service Act.

    Dated: December 16, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-33482 Filed 12-23-97; 8:45 am]
BILLING CODE 4160-01-F