Understanding Regulatory Review in the United States

Medical devices intended for clinical use in the United States are subject to review by the U.S. Food and Drug Administration (FDA). Regulatory review is designed to evaluate a device’s safety, effectiveness, and appropriate use before it may be marketed or used clinically within the U.S. healthcare system.

The regulatory process varies depending on device type, intended use, and risk classification. Review pathways may include evaluation of design, manufacturing controls, testing data, and clinical information, as applicable.

Status of Pectus Up® in the United States

Pectus Up® is a chest wall elevation system that was developed outside the United States and has been used internationally. At this time, Pectus Up® is undergoing U.S. regulatory review for potential future availability.

Until regulatory authorization is granted, Pectus Up® is not available for sale or clinical use in the United States, and no conclusions should be drawn regarding suitability, outcomes, or availability for U.S. patients.

Why Regulatory Status Matters

Regulatory authorization determines when and how a medical technology may be:

• Marketed or promoted
• Used clinically
• Incorporated into training or educational programs
• Discussed in the context of patient care decisions
   

Until authorization is granted, technologies under review are considered investigational from a U.S. regulatory standpoint, and clinical decision-making should continue to rely on currently authorized treatment options and established standards of care.

International Use and U.S. Review

In some cases, medical technologies may have established international clinical experience prior to U.S. regulatory authorization. While international experience may inform design evolution and regulatory evaluation, regulatory decisions, indications, and availability are determined independently within each country.

Information regarding international use is provided for general educational awareness only and does not imply U.S. authorization or clinical applicability.

Ongoing Updates

As regulatory review progresses, publicly available updates may be shared through this website when appropriate.

Individuals and healthcare professionals interested in receiving general educational updates may visit the Request Updates page.