34 Off Label Promotion Medical Device
Allegations often include violations of the federal food drug and cosmetic act the false claims act and the anti kickback statute. The food and drug administration fda has statutory authority to regulate the advertising and promotion of restricted medical devices as well as any medical devices that are not authorized by fda for sale or distribution for their intended use.
Fda Is Illegally Allowing The Off Label Promotion Of Medical
And benefit information for prescription drugs and medical devices.
Off label promotion medical device. Fda guidance documents regarding advertising and promotion. To know more about the promotion advertising rules for medical devices contact us. Heres how fda officials think you can legally promote off label device drug uses june 13 2018 by nancy crotti the fda has issued final guidance clarifying what it considers permissible off label information for device makers and drug companies to convey to potential customers.
As a summary any medical device promotional or samples of medical devices to be made available on the eu market must be in conformity with the above regulatory frameworks either on the device the outer packaging or the ifus. The company allegedly promoted lc bead its embolization devicedesigned to be inserted into blood vessels to block the flow of blood to tumorsfor off label use as a drug delivery device which was not an fda approved use and was not supported by substantial clinical evidence. Implicit off label promotion occurs when a manufacturer indirectly suggests that a device is appropriate for an unapproved use.
The fda has previously developed draft guidance responding to unsolicited requests for off label information about prescription drugs and medical devices that addresses how manufacturers can respond to unsolicited requests for off label information relating to their fda approved or cleared products without such responses being used as evidence of intended use. Promoting off label use of a medical device a use not included on a devices indication with fda has become a dangerous practice for medtech insiders with some facing potential prison time for alleged off label advertising. Off label investigational use of marketed drugs biologics and medical devices information sheet.
For example in 2000 a medical device company that manufactured a product cleared for use as an adjunctive diagnostic screening device for detecting breast cancer received a warning letter from fda. It is conducted in compliance with the requirements concerning the promotion and sale of. Requests for off label information about.
There are tens of thousands of medical devices being advertised and promoted in the us. For medical device the consequences of promoting a product for off label use could be significant.
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