Compliance & Support
USA Protective Care's EncryptorSeal™ technology aligns with multiple federal regulations to enhance
supply chain security, product safety, and compliance. Here are some examples.
MAKE PPE IN AMERICA ACT:
The Make PPE in America Act was created to ensure a secure and reliable supply of personal protective equipment (PPE) by promoting domestic manufacturing. This Act focuses on producing high-quality PPE within the United States to protect healthcare workers and the general public, particularly during emergencies like pandemics.
USA Protective Care's EncryptorSeal™ technology supports companies in aligning with the Make PPE in America Act by enhancing domestic manufacturing capabilities, ensuring quality and safety standards, and improving supply chain transparency. By providing advanced tracking and anti-counterfeit features, EncryptorSeal™ helps companies manage their supply chains efficiently, maintain high-quality production standards, and secure compliance with the Act's requirements. This technology not only strengthens the U.S. PPE supply chain but also fosters economic growth and public trust in American-made PPE.
INFLATION REDUCTION ACT (IRA):
USA Protective Care’s mission to protect American companies and their customers with advanced anti-counterfeit technology and a proprietary health database aligns closely with the goals of the Inflation Reduction Act (IRA). By using this technology, American companies can enhance supply chain resilience by ensuring only genuine products reach the market, supporting the IRA's aim to reduce dependence on counterfeit and foreign goods. This protection helps prevent financial losses and damage to reputation, contributing to economic stability and growth, key objectives of the IRA.
Additionally, USA Protective Care promotes consumer safety and supports sustainability by preventing counterfeit goods, reducing waste, and ensuring authentic, safe products in critical sectors like healthcare. Their innovative technology fosters competitiveness and aligns with the IRA’s focus on advancing American industries through innovation. By leveraging a vast health database, USA Protective Care also aids in data-driven decision-making, enhancing health outcomes and reducing costs, further supporting the IRA’s goals for a stronger, more secure American economy.
FDA'S UNIQUE DEVICE IDENTIFICATION (UDI) PROGRAM:
USA Protective Care’s EncryptorSeal™ technology offers comprehensive solutions that align with the FDA's Unique Device Identification (UDI) legislation, designed to enhance the traceability, safety, and effectiveness of medical devices. EncryptorSeal™ helps manufacturers comply with UDI requirements by assigning unique identifiers to medical devices, such as encrypted QR codes and anti-counterfeit packaging varnish, and automating data capture throughout the supply chain. This technology ensures accurate, real-time tracking and monitoring of devices, facilitates seamless data submission to the FDA's Global Unique Device Identification Database (GUDID), and enhances inventory management and operational efficiency.
EncryptorSeal™ also improves patient safety by ensuring accurate device identification and efficient recall management. The technology supports data-driven decision-making by providing valuable insights into device performance and compliance monitoring. By demonstrating regulatory compliance and enhancing transparency, EncryptorSeal™ helps strengthen brand trust and reputation, aligning with the FDA’s goals of improving device safety and effectiveness.
OTHER LEGISLATION WITH WHICH USA PROTECTIVE CARE IS IN ALIGNMENT:
Under the Drug Supply Chain Security Act (DSCSA), EncryptorSeal™ helps pharmaceutical companies ensure product serialization and traceability, preventing counterfeit drugs from entering the market and maintaining compliance with U.S. regulations. Similarly, it supports the Federal Food, Drug, and Cosmetic Act (FDCA) by maintaining accurate records and preventing counterfeit products, ensuring compliance with safety and labeling standards.
EncryptorSeal also aligns with cybersecurity and consumer protection laws. It enhances data security in line with the Cybersecurity Information Sharing Act (CISA) and supports the Consumer Product Safety Improvement Act (CPSIA) by ensuring products meet safety standards and tracking requirements. Additionally, the technology promotes transparency and ethical sourcing, complying with the Tariff Act of 1930's provisions on forced labor and intellectual property protection.
By fostering innovation and supporting U.S. manufacturers, EncryptorSeal™ also aligns with the American Innovation and Competitiveness Act (AICA) enhancing American competitiveness in advanced technologies. And it aligns with the Federal Acquisition Regulation (FAR) that governs the procurement process of US federal government, ensuring consistency, ethical practice and efficiency across all executive agencies.