How to Market Medical Devices in the U.S.: Key FDA Insights

Entering the United States Medical Device market (the largest in the world) demands a clear understanding of federal regulations. The Food and Drug Administration (FDA), through the Center for Devices and Radiological Health (CDRH), evaluates products based on risk, human factors, and quality standards.

Below is the step-by-step framework to successfully navigate the FDA regulatory process:

1. Risk-Based Classification and Practical Examples for Marketing Medical Devices in the U.S.

To market Medical Devices in the U.S., the FDA classifies them into three categories based on the level of risk and the regulatory control necessary to provide reasonable assurance of safety and effectiveness:

• Class I (Low Risk): Subject only to General Controls (labeling, registration, good manufacturing practices). Most are exempt from premarket notification and/or clearance. For example: Manual surgical scalpels, elastic bandages, examination gloves, tongue depressors, manual wheelchairs.

  
  

• Class II (Moderate Risk): Require General Controls and Special Controls (performance standards, postmarket surveillance, special labeling). Most require 510(k) premarket notifications or De Novo classification requests prior to marketing. For example: Powered wheelchairs, infusion pumps, continuous glucose monitors (CGMs), surgical drapes, electrocardiographs (ECGs), diagnostic ultrasound systems, among others.

  
  

• Class III (High Risk): Devices that support or sustain human life, are implanted, or present a potential unreasonable risk of illness or injury. Require Premarket Approval (PMA). For example: Implantable cardiac pacemakers, coronary stents, mechanical heart valves, deep brain stimulators, silicone gel-filled breast implants.

  
  

2. Regulatory Pathways: Understanding the 510(k), De Novo, and PMA Processes

Once the classification is determined via the FDA database and a Product Code is assigned, manufacturers must choose the appropriate regulatory authorization pathway:

A. 510(k) Premarket Notification

• What it means: A submission demonstrating that the new device is Substantially Equivalent (SE) to a legally marketed predicate device (Class I or II) in terms of intended use, technological characteristics, and safety profile.

• When to use it: When a valid, legally marketed "predicate device" exists.

• Goal: To obtain FDA clearance (a clearance letter) to market the product.

  
  

B. De Novo Classification Request

• What it means: A pathway for novel medical devices that lack a valid predicate, but whose risk profile is low to moderate (warranting Class I or II controls).

• When to use it: When there is no equivalent predicate on the market, but the device does not pose the high risk associated with Class III.

• Goal: To obtain marketing authorization (a granted order) and establish a new device classification, product code, and special controls for future predicates.

  
  

C. Premarket Approval (PMA)

• What it means: The most stringent type of regulatory review. It requires valid scientific evidence (typically prospective clinical trials) demonstrating a reasonable assurance of safety and effectiveness.

• When to use it: Mandatory for Class III high-risk or life-supporting devices.

• Goal: To receive formal FDA approval of the application prior to commercialization.

  
  

3. Mandatory Execution: eSTAR and QMSR Alignment

As of 2026, document and quality management are strictly digital and internationally aligned:

• eSTAR (electronic Submission Template And Resource): A mandatory interactive PDF template for all 510(k) and De Novo submissions. It structures technical documentation, validation data, and human factors reports to avoid initial administrative rejections (Refuse to Accept or RTA).

  
  

• QMSR Compliance: Since February 2026, the FDA updated 21 CFR Part 820 to the Quality Management System Regulation (QMSR), incorporating the ISO 13485:2016 standard by reference. Design controls, risk management, and production controls must reflect this international standard.

  
  

4. Final Step: Establishment Registration and Medical Device Listing

Having a 510(k)-exempt Class I device, obtaining a 510(k) clearance, a De Novo granted order, or a PMA approval does not automatically authorize you to market Medical Devices in the U.S. Before beginning commercial distribution, the manufacturer must complete the operational registration process:

• Annual Establishment Registration: Manufacturing facilities, contract manufacturers, initial importers, and specification developers must register their establishment annually in the FDA's FURLS system.

• MDUFA Fee Payment: Payment of the annual establishment registration user fee is mandatory to activate and maintain the registration.

• Device Listing: Manufacturers must electronically list their medical devices, linking the Product Code and the premarket authorization number (e.g., 510(k) number) to their registered establishment.

• U.S. Agent Designation: Foreign establishments outside the United States must designate a U.S. Agent physically located in the country to act as their official liaison with the FDA.

How to Market Medical Devices in the U.S.: Key FDA Insights

Conclusion

Navigating the FDA regulatory roadmap is a structured process where technical precision dictates commercial success. By correctly identifying device risk, selecting the appropriate pathway (Exempt, 510(k), De Novo, or PMA), complying with the QMSR/ISO 13485 standards, and completing the operational establishment registration and listing, manufacturers turn regulatory requirements into a predictable and successful launch for marketing Medical Devices in the U.S.

Securing commercial success in the world’s most demanding market requires more than just filling out forms; it demands a strategic partner. As experts in FDA medical device regulatory consulting, Sanrubio, LLC combines our experience across the U.S., Latin America, Europe, and Asia to pave your clear path to market.

We offer comprehensive support tailored to your needs:

• Regulatory Strategy: As specialized consultants, we guide you step-by-step from Pre-Submissions, 510(k) notifications, and De Novo classifications, to final authorization and Quality Management System (QMS / QMSR) adaptation.

• Operational Compliance: We manage your FDA establishment registration and device listing from start to finish, including initial setups, annual renewals, and MDUFA fees, ensuring your company operates without legal interruptions.

• Your Gateway to the U.S.: From our strategic location in Miami, we serve as the vital link and trusted U.S. Agent for foreign manufacturers looking to master the American market.

  
  

Ready to bring your medical device to the U.S. market without regulatory delays? Do not risk time and capital on incorrect classifications. Our expert consultants will conduct a preliminary review of your device at no cost.

Free FDA Classification