Description
This guidance document is intended to provide a general description of Food and Drug Administration (FDA or the Agency) export certification to industry and foreign governments. Firms exporting products from the United States are often asked by foreign customers or foreign governments to supply a certification relating to products subject to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and other statutes FDA administers.
Scope & Applicability
Product Classes
3Defined under section 201(i)
Medical devices intended for human use; Approved or cleared medical devices
Jurisdiction of CBER
Stakeholders
1Responsible for ensuring compliance with U.S. statutes
Regulatory Context
Attributes
1Active or Discontinued status in the Orange Book
Related CFR Sections (2)
- 21CFR809.10§ 809.10 Labeling for in vitro diagnostic products.
(a) The label for an in vitro diagnostic product shall state the following information, except where such information is not applicable, or as otherwise specified in a standard for a particular product class or as provided in paragraph (e) of this section. Section 201(k) of the act provides that “a Read full regulation →
- 21CFR312.160§ 312.160 Drugs for investigational use in laboratory research animals or in vitro tests.
(a) Authorization to ship.Read full regulation →