FDA Approval Process for Medical Devices by MDS Finland

MDS Finland offers a comprehensive service to guide medical device manufacturers through the FDA approval process, ensuring access to the U.S. market. This process is essential given the increasing interest in the U.S. market and the lengthening backlogs for certification in the EU. Our services are tailored to the different types of FDA device approvals and clearances.

KEY ASPECTS OF FDA APPROVAL PROCESS SERVICES

510(k) Clearance (Premarket Notification)

The 510(k) process involves submitting a device to the FDA to determine if it is substantially equivalent to a legally marketed device that is not subject to Premarket Approval (PMA).

This pathway often applies to Class II devices and requires a comparison with an existing product (predicate). The typical FDA review time for a 510(k) submission is at least 90 days.

Premarket Approval (PMA)

PMA is required for most Class III devices, which are higher-risk and may support or sustain human life.

This is a more rigorous process where the FDA examines the safety and effectiveness of the device for its intended use. The application includes non-clinical and clinical study summaries among other essential information.

De Novo Classification Request

Suitable for novel medical devices that lack a legally marketed predicate device.

This process involves a risk-based evaluation by the FDA, classifying the device into Class I or II, based on general controls or general and special controls.

Exemptions

Some devices, such as certain Class I and Class II devices, are exempt from 510(k) requirements but still require FDA registration.

Investigational Device Exemption (IDE)

For clinical studies, an IDE allows investigational devices to be used to collect safety and effectiveness data.

Quality System Regulation (QS Regulation)

Manufacturers must adhere to QS regulation, which encompasses requirements related to design, production, labeling, and servicing of medical devices.

OUR COMPREHENSIVE SERVICES INCLUDE

  • Navigating through the regulatory pathways.
  • Preparing and submitting 510(k) notifications or PMA applications.
  • Assisting with clinical studies and IDE applications.
  • Advising on quality system requirements and compliance.
  • Facilitating communications with the FDA.

WHY CHOOSE MDS FINLAND FOR FDA APPROVALS?

Expert Guidance

Our in-depth knowledge of FDA regulations ensures accurate and efficient navigation through the approval process.

Customized Support

We tailor our services to meet the specific needs of your medical device, whether it’s for 510(k) clearance, PMA, or De Novo requests.

Streamlined Process

We aim to simplify and expedite the FDA approval process, allowing you to focus on innovation and market expansion.