What Part of the FDA's Minimal Requirements for Device Labeling

question 5

Multiple Choice

What part of the FDA's minimal requirements for device labeling describes conditions where the risk of use outweighs the anticipated benefits?

• A) Contraindications
• B) Warnings
• C) Boxed warning
• D) Precautions

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Definitions:

EDI

Electronic Data Interchange, a system that allows the exchange of business documents and data across different companies electronically.

B2C

Business-to-Consumer, a commercial transaction model where businesses sell products or services directly to the end-users or consumers.

C2B

Consumer-to-Business, a business model where consumers create value or products that businesses purchase.

B2B

Business-to-Business, a model that involves transactions between two firms rather than between a firm and individual consumers.