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Home » FDA Civil Monetary Penalties Increase with Inflation
FDA Civil Monetary Penalties Increase with Inflation
February 10, 2017
The FDA’s civil monetary penalties are increasing to adjust for inflation at less than 2 percent.
The maximum of aggregated penalties for all violations related to devices in a single proceeding increased to $1.8 million.
Penalties for violating requirements for post-marketing studies, clinical trials, labeling or Risk Evaluation and Mitigation Strategies increased to nearly $290,000.
False or misleading direct-to-consumer advertising will also incur fines of almost $290,000, with subsequent violations in a three-year period drawing penalties of more than $578,000.
Any individual convicted of bribery, destroying documents, or of obstructing an investigation would be subject to a penalty over $426,000. In cases involving more than one individual, the fine will exceed $1.7 million.
The penalty for a supplier that knowingly and willfully charges for a covered prosthetic device, orthotic, or prosthetic that is furnished on a rental basis after the rental payment may no longer be made is increased to more than $15,000.
The new penalties — adjusted for inflation at just over 1.6 percent — apply to all future fines for violations that occurred since Nov. 2, 2015.
The HHS final rule updating civil monetary penalties is available here: www.fdanews.com/02-02-17-HHSMonetaryPenalties.pdf. — Conor Hale
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