Description
Violative imported products should preferably be handled at the port of entry. However, all imported products entered into the United States are not sampled or examined. In fact, most imported articles subject to the agency's jurisdiction are given a "May Proceed Notice" upon entry and are not examined prior to entering domestic commerce. Although the agency attempts to sample or examine as many potentially violative products as possible, it is inevitable that some violative foreign products enter into United States commerce.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
4Subject to sampling requirements under 702(b).; Cosmetic means articles intended to be rubbed, poured, sprinkled, or sprayed on the human body
articles used for food or drink for man or other animals
Defined in section 201(g) of the FD&C Act; Articles intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease; Product classification based on chemical action or specific intended uses like altering pH
FDA intends to assess device cybersecurity based on a number of factors; demonstrate or maintain its safety and effectiveness; ensuring cybersecurity has become essential to FDA’s ability to protect the public health; Cyber-resiliency capabilities for medical devices
Stakeholders
1FDA office that may be consulted regarding requests for sample portions.
Regulatory Context
Regulatory Activities
2Notice given to imported articles not examined at entry
Anticipated legal action under section 304 of the FD&C Act
Attributes
1Lots valued at $1,000 or more
Related CFR Sections (5)
- 21CFR801.15§ 801.15 Medical devices; prominence of required label statements; use of symbols in labeling.
(a) A word, statement, or other information required by or under authority of the act to appear on the label may lack that prominence and conspicuousness required by section 502(c) of the act by reason, among other reasons, of:Read full regulation →
- 21CFR701.2§ 701.2 Form of stating labeling requirements.
(a) A word, statement, or other information required by or under authority of the Act to appear on the label may lack that prominence and conspicuousness required by section 602(c) of the Act by reason (among other reasons) of:Read full regulation →
- 21CFR501.15§ 501.15 Animal food; prominence of required statements.
(a) A word, statement, or other information required by or under authority of the act to appear on the label may lack that prominence and conspicuousness required by section 403(f) of the act by reason (among other reasons) of:Read full regulation →
- 21CFR201.15§ 201.15 Drugs; prominence of required label statements.
(a) A word, statement, or other information required by or under authority of the act to appear on the label may lack that prominence and conspicuousness required by section 502(c) of the act by reason, among other reasons, of:Read full regulation →
- 21CFR101.15§ 101.15 Food; prominence of required statements.
(a) A word, statement, or other information required by or under authority of the act to appear on the label may lack that prominence and conspicuousness required by section 403(f) of the act by reason (among other reasons) of:Read full regulation →
See Also (5)
- CPG Sec. 310.100 Pacemaker Reuse (Status: Final)
- Medical Glove Guidance Manual: Guidance for Industry and FDA Staff (Status: Final)
- CPG Sec 562.750 Labeling of Food Articles Distributed Solely in Puerto Rico (Status: Final)
- Small Entity Compliance Guide: Calorie Labeling of Articles of Food in Vending Machines (Status: Final)
- Guidance for Industry: Labeling of Infant Formula (Status: Final)