Appendix A to Subpart A of Part 26 - List of Applicable Laws, Regulations, and Administrative Provisions
21:1.0.1.1.20.1.63.22.1 : Appendix A
Appendix A to Subpart A of Part 26 - List of Applicable Laws,
Regulations, and Administrative Provisions 1. For the European
Community (EC):
[Copies of EC documents may be obtained from the European
Document Research, 1100 17th St. NW., suite 301, Washington, DC
20036. EC documents may be viewed on the European Commission
Pharmaceuticals Units web site at http://dg3.eudra.org.]
Council Directive 65/65/EEC of 26 January 1965 on the approximation
of provisions laid down by law, regulation, or administrative
action relating to proprietary medicinal products as extended,
widened, and amended. Council Directive 75/319/EEC of 20 May 1975
on the approximation of provisions laid down by law, regulation or
administrative action relating to proprietary medicinal products as
extended, widened and amended. Council Directive 81/851/EEC of 28
September 1981 on the approximation of the laws of the Member
States relating to veterinary medicinal products, as widened and
amended. Commission Directive 91/356/EEC of 13 June 1991 laying
down the principles and guidelines of good manufacturing practice
for medicinal products for human use. Commission Directive
91/412/EEC of 23 July 1991 laying down the principles and
guidelines of good manufacturing practice for veterinary medicinal
products. Council Regulation EEC No 2309/93 of 22 July 1993 laying
down Community procedures for the authorization and supervision of
medicinal products for human and veterinary use and establishing a
European Agency for the Evaluation of Medicinal Products. Council
Directive 92/25/EEC of 31 March 1992 on the wholesale distribution
of medicinal products for human use. Guide to Good Distribution
Practice (94/C 63/03). Current version of the Guide to Good
Manufacturing Practice, Rules Governing Medicinal Products in the
European Community, Volume IV. 2. For the United States:
[Copies of FDA documents may be obtained from the Government
Printing Office, 1510 H St. NW., Washington, DC 20005. FDA
documents, except the FDA Compliance Program Guidance Manual, may
be viewed on FDA's Internet web site at
http://www.fda.gov.]
Relevant sections of the United States Federal Food, Drug, and
Cosmetic Act and the United States Public Health Service Act.
Relevant sections of Title 21, United States Code of Federal
Regulations (CFR) Parts 1-99, Parts 200-299, Parts 500-599, and
Parts 600-799. Relevant sections of the FDA Investigations
Operations Manual, the FDA Regulatory Procedures Manual, the FDA
Compliance Policy Guidance Manual, the FDA Compliance Program
Guidance Manual, and other FDA guidances.
Appendix A to Subpart B of Part 26 - Relevant Legislation, Regulations, and Procedures.
21:1.0.1.1.20.2.63.21.6 : Appendix A
Appendix A to Subpart B of Part 26 - Relevant Legislation,
Regulations, and Procedures. 1. For the European Community (EC) the
following legislation applies to § 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.]
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 § 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).