CFR 21-803.58-2014
Food and Drugs. Part803:Medical device reporting (Eff. 8-14-15). Section803.58:Foreign manufacturers.

Standard No.

CFR 21-803.58-2014

Release Date

2014

Published By

US-CFR-file

Latest

CFR 21-803.58-2014

Scope

(a) Every foreign manufacturer whose devices are distributed in the United States shall designate a U.S. agent to be responsible for reporting in accordance with § 807.40 of this chapter. The U.S. designated agent accepts responsibility for the duties tha

CFR 21-803.58-2014 history

• 2014 CFR 21-803.58-2014 Food and Drugs. Part803:Medical device reporting (Eff. 8-14-15). Section803.58:Foreign manufacturers.