FDA Relabeler Definition: Compliance, Regulations, and Best Practices for 3PL & FTZ Businesses

Stu Spikerman

April 9, 2025

FDA Relabeler Definition and Why It Matters

At Tri-Link FTZ, we’ve spent decades helping businesses streamline their third-party logistics (3PL) and foreign trade zone (FTZ) operations. One of the most overlooked yet crucial aspects of compliance is FDA relabeling—a process that can be a game-changer for medical device and pharmaceutical companies.

So, what exactly is an FDA relabeler? According to the FDA, a relabeler is any company that modifies the existing labeling of a medical device or pharmaceutical product before it reaches the market. 

This could mean adding a new brand name, updating instructions for use, or even changing regulatory details to meet compliance in different markets. Unlike repackagers—who change the physical packaging of a product—relabelers focus strictly on the labeling. 

It’s a small but vital distinction because the FDA classifies relabelers as manufacturers, meaning they must comply with strict federal regulations. Whether you’re an importer, distributor, or contract manufacturer, understanding these rules can mean the difference between a smooth operation and an FDA warning letter.

TL;DR (Too Long; Didn’t Read)

  • An FDA relabeler is a company that changes the labeling of a medical device or pharmaceutical product before distribution.
  • Relabeling is a regulated activity under the FDA’s rules and requires establishment registration, medical device listing, and compliance with FDA regulations.
  • Relabelers must understand the differences between relabeling, repackaging, and manufacturing to ensure full compliance.
  • Failure to follow FDA guidelines can result in penalties, recalls, and enforcement actions, making compliance a top priority.
  • Tri-Link FTZ, with 35 years of experience in third-party logistics and foreign trade zones, helps businesses navigate complex FDA relabeling requirements to ensure regulatory success.
Business professionals discussing FDA relabeler definition and compliance strategies in a corporate setting.

Regulatory Requirements for FDA Relabelers

Navigating FDA regulations is no easy task, and as a third-party logistics company with over 35 years of experience, we’ve seen companies struggle with relabeling compliance time and time again. The FDA requires all relabelers to register and list their products, but the process is more complicated than just filling out a form.

At a minimum, an FDA relabeler must:

  • Register their establishment as a relabeler with the FDA under 21 CFR Part 807.
  • List each medical device they relabel in the FDA’s Device Registration and Listing Database.
  • Ensure compliance with Unique Device Identification (UDI) requirements, which allow the FDA to track medical devices through their lifecycle.
  • Follow Good Manufacturing Practices (GMP) to maintain consistency and avoid potential safety risks.
  • Determine if a 510(k) or PMA submission is needed, depending on the nature of the relabeling changes.

For companies operating within a foreign trade zone (FTZ) like Tri-Link FTZ, these regulations can add an extra layer of complexity. Products stored in an FTZ may require specific labeling updates before entering U.S. commerce, making it essential to partner with compliance experts who understand the nuances of FDA regulations.

How to Register as an FDA Relabeler

FDA registration isn’t just a formality—it’s a mandatory process that ensures safety, traceability, and accountability within the supply chain. At Tri-Link FTZ, we guide businesses through every step of the registration process to ensure full compliance.

The FDA Establishment Registration process for relabelers includes:

  1. Creating an account on the FDA’s FURLS (FDA Unified Registration and Listing System).
  2. Submitting an application with detailed business information, including the nature of the relabeling activities.
  3. Listing each device in the FDA Device Listing Database, ensuring the correct product details match regulatory standards.
  4. Paying the annual FDA establishment registration fee, which varies depending on the size and scope of operations.
  5. Maintaining compliance records, as the FDA conducts random inspections and audits to verify regulatory adherence.

For businesses managing large-scale distribution operations, these steps can be overwhelming. That’s where third-party logistics providers like Tri-Link FTZ come in—we handle the compliance burden so that businesses can focus on growth and market expansion.

Compliance Risks and Common Pitfalls for FDA Relabelers

Over the years, we’ve worked with numerous companies that have unknowingly violated FDA relabeling rules, often due to minor oversights. The consequences of non-compliance can be severe, ranging from warning letters to product recalls and even civil penalties.

Some of the most common compliance risks for relabelers include:

  • Failing to properly update device listings, leading to discrepancies in FDA databases.
  • Using non-compliant labeling formats that do not meet UDI or GMP standards.
  • Altering product information in a way that requires a new 510(k) submission, without realizing it.
  • Not keeping accurate records, which can result in penalties if an FDA audit occurs.
  • Misclassifying relabeling activities, causing confusion in regulatory filings.

The best way to avoid these issues is by working with an experienced compliance team that understands the ins and outs of FDA regulations. Read more here.

Two coworkers discussing FDA relabeler definition and its role in medical device compliance at an office table.

Best Practices for FDA-Compliant Relabeling

Compliance isn’t just about checking off boxes—it’s about creating a structured, transparent process that ensures long-term success. At Tri-Link FTZ, we recommend these best practices for businesses engaging in FDA relabeling.

  • Standardize labeling processes to ensure consistency across all relabeled products.
  • Use compliance software to track regulatory changes and maintain accurate records.
  • Regularly audit labeling practices to identify and correct potential compliance gaps.
  • Train employees on FDA regulations to minimize mistakes in relabeling activities.
  • Work with third-party logistics providers who specialize in regulatory compliance.

By implementing these strategies, businesses can minimize risk and streamline their operations while ensuring full FDA compliance. Read more here.

Legal Considerations for FDA Relabelers

Beyond compliance, relabelers must also consider the legal implications of altering product labels. At Tri-Link FTZ, we’ve seen cases where poor relabeling decisions led to liability issues, product recalls, and even lawsuits.

Relabelers must understand:

  • Who holds legal responsibility in the event of a product defect or recall.
  • How relabeling impacts warranties, and whether additional liability coverage is necessary.
  • The risks of altering labeling claims, which can inadvertently misrepresent a product’s intended use.
  • The potential for intellectual property conflicts, especially if rebranded products closely resemble the OEM’s labeling.
  • How the FDA enforces relabeling violations, including fines and legal penalties.

Navigating these complexities requires a proactive approach—something we specialize in at Tri-Link FTZ.

Conclusion: Ensuring Compliance and Efficiency in FDA Relabeling

FDA relabeling is a critical, highly regulated process that demands strict compliance and careful oversight. At Tri-Link FTZ, we leverage our 35 years of expertise in third-party logistics and foreign trade zones to help businesses navigate complex FDA regulations with ease.

By understanding the FDA relabeler definition, complying with registration and listing requirements, and following best practices, businesses can avoid regulatory pitfalls and stay ahead of compliance challenges. Our team ensures that clients meet all necessary requirements while streamlining their operations for long-term success.

If you’re looking for a trusted partner in FDA compliance and logistics, Tri-Link FTZ is here to help. Contact us today to learn how we can assist with FDA relabeling, compliance, and regulatory strategy.

Share this article

Other Articles

Need More Information?

We have other resources available upon request as well as one-on-one support and personalized answers, just like our services.

Simply contact us anytime and we’ll get back to you to answer your questions and provide meaningful answers that show you how Tri-Link supports your logistics, reduces costs, and accelerates efficiency.

  • Reach out!
    +1-888-487-7707

Tri-Link delivers exceptional FTZ and 3PL services tailored to your global trade needs.

Our solutions combine innovation, quality, and efficiency to exceed your expectations and meet your specific requirements.

General
Services
Call Us!

Empowering Your Global Trade

© Tri-Link FTZ 2025, All Rights Reserved

WEBSITE BY VIBE BRANDING