Abstract: When the Food and Drug Administration (FDA) obtains information that an FDA-regulated product poses a risk to the public health, the FDA priority is to determine whether the product should be removed from the marketplace and if so, to take swift action to ensure public notification and removal. This is typically accomplished most expeditiously by voluntary corrective efforts by the responsible firm(s). The FDA can utilize advisory actions, administrative actions, and enforcement actions when a firm's voluntary action is not rapid, complete, or the firm is uncooperative. The FDA takes enforcement action to bring medical device manufacturers into compliance when manufacturers may not be complying with medical device laws. However, relying on enforcement actions alone does not necessarily lead to or result in manufacturers focusing on improving the quality of their products.
Publication Year: 2023
Publication Date: 2023-01-01
Language: en
Type: book-chapter
Indexed In: ['crossref']
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