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Intellectual Property Issues in Medical Device Labeling and Marketing

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FDA and Intellectual Property Strategies for Medical Device Technologies

Abstract

Apart from whether a mark can be protected under the trademark law, there may be government regulations that can restrict or prohibit use of the mark in advertising or labeling any products with the mark. Any medical device company using or selecting a trademark should be aware of the nature and kind of regulations that may be applicable to their product. The rules vary from state to state, and there are different rules that apply to labeling and marketing outside of the United States. Medical device companies need to be aware of what labeling and marketing rules apply to their business in order to avoid potential fines, penalties or litigation.

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References

  1. 21 C.F.R. § 801.420-801.421.

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  2. 21 C.F.R. § 809.30.

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  3. 21 C.F.R. § 809.40.

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Halt, G.B., Donch, J.C., Stiles, A.R., VanLuvanee, L.J., Theiss, B.R., Blue, D.L. (2019). Intellectual Property Issues in Medical Device Labeling and Marketing. In: FDA and Intellectual Property Strategies for Medical Device Technologies. Springer, Cham. https://doi.org/10.1007/978-3-030-04462-6_11

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  • DOI: https://doi.org/10.1007/978-3-030-04462-6_11

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  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-030-04461-9

  • Online ISBN: 978-3-030-04462-6

  • eBook Packages: EngineeringEngineering (R0)

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