Avoid Criminal Penalties for TAA Compliance for Medical Equipment in GSA ContractsWhen selling medical equipment or devices to the federal government under GSA contracts, getting Trade Agreement Act compliant is critical for both the equipment and the end products.
The Trade Agreements Act (TAA), 19 USC 2501 sets forth specific regulations that govern the eligibility of products to be sold to the government.
It is crucial for companies to understand their obligations and ensure TAA statutory compliance to avoid severe consequences for incorrectly certifying their products as TAA compliant products. In such cases, having the expertise of government contracts TAA compliance attorneys becomes invaluable. See the article about the company that knowingly manufactured medical products in China and Malaysia for sale to the Departments of Defense and Veterans Affairs despite the prohibition of the Trade Agreements Act.
The Department of Justice (DOJ) and various federal agencies are paying more and more attention to providers of medical supplies, and pursuing them for submitting false claims to the government for payment relating to sales of medical supplies.
19 USC 2501 Trade Agreements Act Requirements
The Trade Agreements Act (“TAA”) requires that products sold to government agencies must come only from countries with which the United States has a trade agreement. While many countries qualify as TAA-compliant countries, some TAA non compliant countries like China and Malaysia, do not. Government contractors and manufacturers selling from these countries to government agencies can be in violation of the TAA.
If medical product manufacturers provide the government with TAA certification, the consequences of false certification can be disastrous. At Watson & Associates, LLC, our Washington DC 19 USC 2501 Trade Agreements Act attorneys help federal contractors and manufacturers locally and overseas reduce their chances of being investigated or charged criminally with violating TAA regulations.
TAA Non Compliant Countries
Examples of TAA non compliant countries include China, India, Indonesia, Iran, Iraq, Malaysia, Pakistan, and Russia. If you are a GSA Schedule contractor, you must understand “substantially transformation” and the “Country of Origin” for each product and service under your GSA TAA compliance rules. This is especially important for Dealers, Resellers , and manufacturers who do not control the manufacturing process and often rely on box markings and incomplete information.
TAA Requirement for Medical Products and Equipment Sold to the Federal Government
Under GSA contracts, medical equipment and devices sold to the federal government must comply with the TAA. This act requires that products originate from designated countries or countries that have certain trade agreements with the United States. The TAA is essential to ensure fair trade practices and promote economic relationships with eligible countries. See more on how to respond to a subpoena duces tecum.
What Makes Your Medical Devices TAA Compliant Products Under 19 USC 2501-2581?
When you sell medical devices or products to the federal government, through GSA or otherwise, the government can only procure products or services from designated countries: for your medical devices to be TAA compliant products under 19 USC 2501-2581, it is your responsibility to make sure that your products sold through GSA contracts to the government are manufactured or substantially transformed in a designated country. There is no magic formula where one size fits all. Courts have ruled that each case is fact-specific.
Why are Medical Device and Product Manufacturers Being Investigated and Criminally Charged?
When medical products and equipment do not comply with TAA requirements – 19 USC 2501-2581, whistleblowers and agencies may report the company to federal law enforcement. As a result, an TAA compliance investigation starts and you are then subject to the reach of the federal government and even being charged / indicted for a felony.
In one case, the DOJ claimed that a manufacturer knowingly manufactured medical products in China and Malaysia for sale to the Departments of Defense and Veterans Affairs despite the Trade Agreements Act prohibition. In that case, Ambu, a provider of medical supplies, submitted false claims to the Defense Logistics Agency (“DLA”) and the Department of Veterans’ Affairs (“VA”) for payment relating to its sales of medical supplies. The Trade Agreements Act (“TAA”) requires that medical products sold to the. federal government agencies must come only from countries with which the United States has a trade agreement. While many international countries qualify as TAA compliant countries, China and Malaysia do not. Ambu began manufacturing its products in these countries and selling them to government agencies in violation of the TAA.
This is but only one example where a company paid $3.3 million to resolve False Claims Act allegations of not being TAA compliant.
The Consequences of Incorrectly Certifying TAA Compliance Requirements for Medical Products
Incorrectly certifying under 19 USC 2501-2581 that medical equipment or devices are TAA compliant can have severe consequences for businesses. The federal government takes TAA compliance seriously and actively investigates potential violations and may charge companies with felony criminal liability.
Companies found to be non-compliant may face financial civil and criminal penalties, exclusion via suspension and or debarment from future contracts. These penalties and consequences can have significant financial and reputational implications, jeopardizing the business’s relationships and standing within the government contracting community.
Having 19 USC 2501-2581 Trade Agreements Act compliance attorneys to help your company through the maze of complex and confusing TAA compliance requirements can make a huge difference and reduce the chance of exposure to paying millions of dollars and even jail time.
The Role of FAR 52.225-5 Government Contracts TAA Compliance Attorneys
Navigating the complexities of the Trade Agreements Act in the government contracting realm requires specialized knowledge and experience. Government contracts TAA compliance attorneys are well-versed in the intricacies of. FAR 52.225-5 TAA regulations and can provide invaluable guidance and support. These attorneys understand the TAA requirements for medical equipment and deeply understand the potential pitfalls and challenges that companies may face. They can assist in ensuring proper compliance, developing robust compliance programs, and responding to government inquiries or investigations.
The Benefits of Having Government Contracts TAA Attorneys
Theodore P. Watson, Lead TAA compliance lawyer. Engaging government contracts, TAA attorneys offer numerous benefits for companies in the medical equipment industry.Speak directly to Mr. Watson. Call 1.866.601.5518.
Trade Agreements Act investigation attorneys and criminal defense lawyers possess a comprehensive understanding of TAA regulations and keep abreast of any changes or updates that may impact compliance requirements.
Their expertise allows them to navigate the complexities of the TAA identify potential compliance issues, and develop strategies to mitigate risks. With their guidance, companies can confidently pursue government contracts, ensuring that their medical equipment or devices are in a better position to meet the stringent TAA compliance requirements.
Becoming TAA compliant is a crucial requirement for medical equipment and device manufacturers selling to the federal government under GSA contracts. Incorrectly certifying compliance with TAA regulations can lead to severe consequences, including financial penalties and exclusion from future contracts. Engaging the services of government contracts Trade Agreements Act compliance attorneys provides companies with the expertise needed to navigate TAA regulations, mitigate compliance risks, and ensure adherence to the requirements.
Contact our law firm today to discuss your TAA compliance requirement and needs for your medical products and let our experienced Trade Agreements Act attorneys safeguard your interests and protect your business from potential compliance pitfalls and criminal felonies. Call today at 1.866.601.5518. Speak to Theodore Watson.