[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR26B App A]

[Page 258-259]

                        TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
                                SERVICES

   PART 26_MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE
PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY--Table of Contents

        Subpart B_Specific Sector Provisions for Medical Devices

Sec. Appendix A to Subpart B of Part 26--Relevant Legislation,
                      Regulations, and Procedures.

1. For the European Community (EC) the following legislation applies to
                     Sec.  26.42(a) of this subpart:

    [Copies of EC documents may be obtained from the European Document
Research, 1100 17th St. NW., suite 301, Washington, DC 20036.]

[[Page 259]]

a. Council Directive 90/385/EEC of 20 June 1990 on active implantable
medical devices
    OJ No. L 189, 20.7. 1990, p. 17. Conformity assessment procedures.
    Annex 2 (with the exception of section 4)
    Annex 4
    Annex 5
b. Council Directive 93/42/EEC of 14 June 1993 on Medical Devices OJ No.
L 169,12.7.1993, p.1. Conformity assessment procedures.
    Annex 2 (with the exception of section 4)
    Annex 3
    Annex 4
    Annex 5
    Annex 6

  2. For the United States, the following legislation applies to Sec.
                                26.32(a):

    [Copies of FDA documents may be obtained from the Government
Printing Office, 1510 H St. NW., Washington, DC 20005. FDA documents may
be viewed on FDA's Internet web site at http://www.fda.gov.]
a. The Federal Food, Drug and Cosmetic Act, 21 U.S.C. 321 et seq.
b. The Public Health Service Act, 42 U.S.C. 201 et seq.
c. Regulations of the United States Food and Drug Administration found
at 21 CFR, in particular, Parts 800 to 1299.
d. Medical Devices; Third Party Review of Selected Premarket
Notifications; Pilot Program, 61 FR 14789-14796 (April 3, 1996).
e. Draft Guidance Document on Accredited Persons Program, 63 FR 28392
(May 22, 1998).
f. Draft Guidance for Staff, Industry and Third Parties, Third Party
Programs under the Sectoral Annex on Medical Devices to the Agreement on
Mutual Recognition Between the United States of America and the European
Community (MRA), 63 FR 36240 (July 2, 1998).
g. Guidance Document on Use of Standards, 63 FR 9561 (February 25,
1998).