FDA 510(k) Submissions for Obtaining FDA Approval (Clearance)
Emergo Group assists medical device companies from around the world seeking "FDA approval" to sell their products in the United States. One of the first steps for medical device companies who manufacture Class 2 devices (and a small number of Class 1 and 3 devices) is to file a Premarket Notification with the Food and Drug Administration, also known as an FDA 510(k) submission.
Technically, the FDA does not "approve" Class 1 and 2 medical devices for sale in the US they give "clearance" for them to be sold. We use the term "FDA approval" for simplicity. To be cleared for sale by the FDA, the first step is to identify a Predicate Device(s), a device similar to the one for which FDA approval is being sought.
We have successfully prepared and submitted FDA 510(k) submissions for hundreds of medical device and IVD companies worldwide.
See a diagram of the US FDA 510(k) clearance process.
Who must submit a FDA 510(k) Premarket Notification?
In general, manufacturers introducing Class 2 medical devices to the US must submit a FDA 510(k). A similar predicate device that is already cleared by the FDA must be identified. A 510(k) is also required for manufacturers that are changing the intended use of the medical device, or changing the technology of a cleared device in such a way that it may significantly affect its safety or effectiveness.
See a list of devices EXEMPT from the FDA 510(k) process.
Our FDA 510(k) preparation and submission services include:
- Identify a predicate device(s) or verify that the predicate device(s) used in your submission meets FDA criteria.
- Write the "substantial equivalence" section of the 510 (k) that compares your device to the predicate device(s).
- Determine if FDA Guidance Documents are applicable to your medical device.
- Contact the FDA Office of Device Evaluation to determine any special requirements for their review of this product, if necessary.
- Prepare and submit the FDA 510 (k) application to the FDA in electronic and hard copy format.
- Write the Executive Summary section of the 510 (k).
- Coordinate with you and the FDA reviewer, and assist with the preparation of a response if the FDA has questions or requires additional information.
- Monitor the progress of the FDA 510 (k) Pre Market Notification through the FDA review process and supply you with periodic updates as they become available.
Please contact us for more information or a free proposal on obtaining US FDA 510(k) clearance for your medical device.
