FDA 510K certification
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Medical device certifications
With our expertise and resources, we can help you to obtaining FDA 510k medical device certification.
The FDA 510k certification is a pre-market submission made by medical device manufacturers to prove that their device is safe and effective for clinical use. This certification is essential for products that resemble or modify an existing device or technology.
Steps to obtain FDA 510K certification
- Device classification - Identify the class of your device and FDA regulatory requirements involved.
- Formulate your submission - Prepare an FDA 510k application with the needed documents and details.
- Submission of application - Submit your application through the FDA online system.
- FDA Review - The FDA will review your application and give feedback after the acceptance period.
Steps to obtain FDA 510K certification
1. Submission process
Ensure that your application submission is complete, accurate, and follows all guidelines.
2. Timeline
The application review timeline varies based on the scope of the device, but processing can typically be completed within three months.
3. Required forms
The application consists of several forms, including a device description, indication for use, and financial disclosure statements that must be filled out accurately.
Key requirements for FDA 510K clearance
1. Substantial equivalent
Devices should be the same as a device cleared for the market or prove a safer and more effective alternative to current devices.
2. Clinical performance
Manufacturers are required to demonstrate the safety and efficiency of their devices in comparison to the existing devices.
3. Device classification
Identifying the right classification of devices according to FDA guidelines is critical to the review process.
Common reason for FDA clearance delays
- Missing information or documentation in your application
- Device malfunction or technical issues
- Incorrect testing procedures
- Lack of communication with the FDA during the review process
- Device design flaws or unexpected side-effects
Frequently Asked Questions
What is the cost of 510k clearance?
The expenses involved in overhauling the medical device for compliance can be quite expensive, but they vary based on the type of device.
Does the FDA conduct testing on my device?
The FDA does not perform testing on medical devices submitted for clearance, but they do review your testing results.
How long is the FDA 510k clearance valid?
Although the clearance can be granted, it doesn’t imply that it will remain valid for an indefinite period. A clearance is valid for approximately three years.
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