FDA Compliance for Access to the U.S. Market

To enter the U.S. market

The United States is a major market for medical devices.

The marketing of a medical device in the United States must comply with specific regulatory requirements established by the Food and Drug Administration (FDA).

Depending on the type of device, its intended use, and its risk level, different regulatory pathways may apply, including 510(k), De Novo, or Premarket Approval (PMA) procedures.

CISTEO Medical assists manufacturers, startups, and spin-offs in defining their regulatory strategy and compiling the necessary documentation to bring their medical devices to market in the United States.

Understanding the FDA Regulatory System

Gaining access to the U.S. market requires accurately determining the regulatory pathway that applies to your device. The FDA distinguishes between several marketing pathways based on classification, risk level, and whether or not a comparable device is already legally marketed.

The most common pathways include the 510(k) procedure, De Novo classification, and the Premarket Approval (PMA) procedure for certain high-risk devices.

510(k) — Demonstratesubstantial equivalence to a device already on the market in the United States (Predicate Device).
De Novo — For certain innovative devices with low or moderate risk when no appropriate predicate device exists.
PMA — The most rigorous procedure, intended primarily for Class III devices that require a thorough demonstration of their safety and effectiveness.

Cisteo MEDICAL works with you from the very beginning of your project to identify your product’s regulatory status, analyze its classification, and determine the most appropriate regulatory pathway. This approach allows regulatory requirements to be progressively integrated into the device’s development, from the initial feasibility studies through to the preparation for market launch.

Our Support for FDA Compliance of Your Medical Devices

Cisteo MEDICAL assists you in developing your regulatory strategy and in compiling the necessary documentation for your project.

Regulatory Strategy
FDA classification, product code, identification of a predicate device, and determination of the market access pathway.
Documentation & Bidding
Analysis of the existing system, identification of gaps, compilation of technical documentation, and preparation of bids, particularly in eSTAR format where applicable.
Quality & Compliance
Analysis of U.S. quality requirements and support for compliance.

Our support is tailored to both startups developing a new medical device and manufacturers seeking to organize or complete their regulatory dossier.

Why Choose Cisteo MEDICAL?

Cisteo MEDICAL supports medical device manufacturers in their FDA regulatory strategy, from the initial project definition through to market launch in the United States.

Our expertise is based on:

Expertise in medical devices and their lifecycle.
Expertise in FDA regulatory pathways: 510(k), De Novo, and PMA.
A regulatory strategy tailored to each system and its level of maturity.
Support for technical documentation and bid preparation.
An integrated approach to industrial challenges, from design to production.
Long-term support, particularly for the development and maintenance of the system in the U.S. market.

Cisteo MEDICAL offers a pragmatic approach , tailored to each project and focused on bringing products to market.