The U.S. remains one of the most competitive and tightly regulated markets for medical devices. But even with a high-quality product, many companies face costly delays—not because of flaws in the technology, but due to gaps in documentation or misunderstanding of regulatory requirements.

That’s why Hansem Global, a leading provider of multilingual documentation and regulatory content development, and Amin Wasserman Gurnani LLP (AWG), a renowned U.S.-based FDA regulatory law firm, have joined forces.

By combining Hansem Global’s strength in medical labeling, IFU structuring, and multilingual compliance documentation with AWG’s unparalleled expertise in FDA legal strategy and regulatory compliance, we provide an integrated, practical solution for medical device companies preparing to enter the U.S. market.

This article explains the key regulatory requirements for medical devices in the United States—and how our partnership can help ensure your documentation and compliance strategy is sound from the start.

FDA Regulatory Requirements: What Must Be Prepared

To legally market a medical device in the U.S., companies—foreign or domestic—must comply with several key regulations. Here’s what you need to prepare:

1. Medical Device Labeling (21 CFR Part 801)
Labeling goes beyond the immediate product label. It includes instructions for use, contraindications, warnings, and precautions and must be presented in English. Websites, marketing brochures and social media posts can be deemed promotional labeling. Incomplete or inaccurate labeling is one of the most common causes of delay. In addition, labeling claims must be supported by appropriate data and be allowable for your type of device.

2. Unique Device Identification (UDI) – (21 CFR Parts 801 & 830)
Almost every device model or version must have a UDI on its label and be registered in the FDA’s GUDID database. Incorrect or missing UDIs and registrations can lead to problems in distribution and recall management.

3. Establishment Registration & Device Listing (21 CFR Part 807)
Manufacturers and certain other parties must register their facilities (establishment registration) and list each device type they market or handle with the FDA. This is required at the start of marketing and then annually and is mandatory for both U.S. and non-U.S. manufacturers and other parties.

4. Marketing Applications: 510(k), PMA, De Novo (21 CFR Parts 807, 814, 860)
Depending on the device class, different premarket submission pathways apply:

• Class I: Often exempt from premarket notification (510(k) submission)
• Class II: Often requires a 510(k) submission or De Novo submission
• Class III: Requires a PMA
  Each path requires specific documentation, safety effectiveness data, including sometimes clinical trial and human factors evidence.

5. Quality System Regulation (QSR) – (21 CFR Part 820)
FDA requires manufacturers to implement a quality system that covers design, manufacturing, packaging, labeling, storage, and more. While similar to ISO 13485, the QSR has unique requirements which must be met to be in compliance. Manufacturers also must prepare for FDA’s transition from the QSR to the Quality System Management Regulation in February 2026. Failure to comply with the QSR can trigger an FDA enforcement action.

6. Medical Device Reporting (MDR) – (21 CFR Part 803)
Post-market adverse event reporting and record keeping are mandatory. Failing to maintain a compliant reporting system can result in serious regulatory enforcement actions.

Prepare the Right Way—From the Start

FDA requirements are strict—but predictable. With the proper support, you can mitigate risk, expedite market entry, and safeguard your business.

Why Hansem Global and AWG Law Can Support You

📌 Hansem Global: Documentation, IFU Development, and Global Language Support
With over 35 years of experience, Hansem Global supports clients in building FDA-compliant documentation that is clear, structured, and multilingual-ready. Our strengths include:

• Developing and localizing Instructions for Use (IFUs) and medical device labels
• Ensuring consistency with 21 CFR Part 801 for safety and warning content
• Translating technical content into 50+ languages, aligned with regulatory tone
• Supporting digital templates, version control, and QA across document types

📌 AWG Law: FDA Regulatory Legal Counsel and Strategy
AWG provides strategic legal guidance throughout the U.S. FDA regulatory process. The firm’s capabilities include:

• Identifying the correct regulatory pathway: 510(k), PMA, De Novo or Exempt
• Supporting Establishment Registration and Device Listing procedures
• UDI planning and GUDID database registration
• Advising on QSR compliance and FDA audit readiness
• Assisting with MDR procedures and issues
• Responding to FDA Warning Letters and enforcement actions

Together, we cover both sides of the challenge:
The documentation and language precision you need
The legal and procedural oversight to ensure compliance

Let’s Prepare the Right Way—From the Start

Hansem Global and AWG Law help you get it right—from the very first draft of your IFU to the final FDA submission. → Visit www.hansem.com to see how Hansem Global supports regulatory documentation and multilingual compliance.
→ For legal consultation, reach out to AWG:
Neil O’Flaherty, Partner | ✉️ noflaherty@awglaw.com | 🌐 www.awglaw.com