Swayed By Industry Opposition To 'Intended Use' Rule, FDA Definitively Delays Implementation

US FDA is considering calls to drop 'totality of circumstances' test and to clarify that mere knowledge of unapproved use does not constitute evidence the use was intended.

The question mark in a number of

The US FDA is putting off a decision on the scope of its final rule regarding the evidence the agency considers in determining how a manufacturer intends its product to be used. However, the agency seems to agree with industry that the rule needs to be revised to make it clear certain communications will not expose companies to potential liability.

In January, the agency announced a proposal to delay implementation of amendments to the medical product "intended use" regulations for...

More from Marketing & Advertising

More from Compliance