FDA ENFORCEMENT

 

The FDA can impose civil monetary penalties (CMPs) on medical device manufacturers for violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The amount of the CMP can vary depending on the severity of the violation, but it can be up to $15,000 for each violation.

Here are some examples of FDA fines against medical device manufacturers:

• In 2020, the FDA fined Medtronic $20 million for failing to report to the agency about a defect in its MiniMed insulin pumps that could have caused serious injuries or death.
• In 2019, the FDA fined Johnson & Johnson $12.8 million for failing to properly investigate and report complaints about its Ethicon Physiomesh hernia mesh.
• In 2018, the FDA fined Boston Scientific $10 million for failing to properly investigate and report complaints about its Taxus stent.

The FDA can also take other enforcement actions against medical device manufacturers, such as issuing warning letters, suspending or revoking marketing authorizations, and seizing products.

The FDA's medical device regulations are complex and ever-changing.

Manufacturers of medical devices should always retain an experienced quality regulatory affairs professional to ensure that they remain in compliance at all times.