510(k) Submission Support for Medical Devices

We can support in the full process of submitting  510(k) application and obtain clearance:

• Gap Analysis and proper classification of the medical device
• Definition of substantial equivalent product
• Review of applicable standard and execution of any additional tests
• Drafting of the full application
• Submission on eStar
• SMALL BUSINESS procedure assistance 
• ESTABLISHMENT REGISTRATION, LISTING, GUDID        
• US agent support
• US Importer support

Reach out now to evaluate the best strategy for your case: info@tsquality.ch

What is a 510(k)

510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, substantially equivalent, to a legally marketed device that is not subject to premarket approval. The name comes from the section 510(k) of the Federal Food, Drug and Cosmetic Act (FDCA).

CE marked and FDA approved medical devices on the Swiss market

At the moment, Switzerland is still recognizing EU CE Marked devices, although with the additional requirement to appoint a Swiss Authorized Representative. However, the Parliament expressed its concerns over potential shortages of high-quality medical devices and has now decided to open up the Swiss market also to US Food & Drug Administration (FDA) approved medical devices.

Usefull Links:

• FDA Official page for 510(k)
• 510(k) Decision-Making Flowchart
• Search the releasable 510(k) database
• Recognized Consensus Standards: Medical Device

Reach out now to evaluate the best strategy for your case: info@tsquality.ch

Which devices are eligible for 510(k)

The full list of medical devices eligible for 510(k) Premarket Notification is published and maintained updated by the FDA, and contains the classification regulation number for each device (generic type of device), the name of the device and its class, device-specific guidance or general guidance to assist manufacturers in the preparation of the documentation.

Here are the main categories based on the device’s purpose:

Reach out now to evaluate the best strategy for your case: info@tsquality.ch.