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e. Draft Guidance Document on Accredited Persons Program, 63 FR 28392 (May 22, 1998).

f. Draft Guidance for Staff, Industry and Third Parties, Third Party Programs under the Sectoral Annex on Medical Devices to the Agreement on Mutual Recognition Between the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).