FDA Approval

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 FDA consultancy services are tailored to the different types of FDA device approvals and clearances, including 510(k) submissions, PMA, DeNovo requests, and IDE-applications, as well as full support with US registration and compliance with Quality System Regulation (QSR).

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 US registration with the FDA.

IDE-Application (Investigational Device Exemption)

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

Quality System Regulation (QSR)

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

What our FDA Approval Services Include

  • Navigating through the appropriate FDA approval pathways
  • Preparing and submitting 510(k) notifications DeNovo, or PMA applications
  • Assisting with clinical studies and IDE-applications
  •  Advising on QSR and documentation requirements
  • Supporting US registration, establishment registration, and device listings
  • Facilitating communication 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 FDA approval process, from strategy to submission.

Customized Support

We tailor our FDA consultancy services to meet the specific needs of your medical device—whether it’s for 510(k) clearance, PMA, DeNovo, or an IDE-application—ensuring your path to market is clear and achievable.

Streamlined Process

We simplify and accelerate the FDA approval process, managing everything from US registration to regulatory communication so you can focus on innovation and market expansion.

Navigating the U.S. Regulatory Landscape

Partnering with MDS Finland for FDA consultancy ensures that your medical devices meet all necessary requirements for successful entry into the U.S. market. Our comprehensive approach to FDA approval provides clarity, confidence, and compliance at every stage.