ANSWERED ON THIS PAGE:
- Which medical device classifications require an FDA 510(k)?
- What are the phases of the 510(k) preparation process?
- How long is our 510(k) clearance valid?
One of the first steps toward selling a Class II medical device or IVD in the United States is to file a Premarket Notification with the FDA, also known as an FDA 510(k) submission. Technically, the FDA does not "approve" medical devices or IVDs for sale under the 510(k) process; the agency gives "clearance" for them to be sold in the U.S. We use the terms "FDA approval" and "FDA clearance" interchangeably.
Who must submit an FDA 510(k) premarket notification?
In general, manufacturers wishing to introduce Class II medical devices (and a small number of Class I and III devices) or IVDs to the US market must submit a 510(k) to the FDA. A 510(k) premarket notification is also required for manufacturers changing the intended use of their medical device, or changing the technology of a cleared device in such a way that it may significantly affect the device's safety or effectiveness.
Prepare fast, efficient 510(k) submissions with RAMS Smart Builder
Smart Builder is one of the premium services available as part of our digital RA/QA platform, Regulatory Affairs Management Suite (RAMS). With support for multiple regulatory activities including US FDA 510(k) premarket clearance, Smart Builder provides step-by-step guides to prepare your submission. The innovative Keyword feature allows you to make global edits to key textual components such as the product name and Indications for Use, and the comment system helps your team to collaborate effectively.
How we help with US FDA 510(k) submissions
To support a successful 510(k) submission, we take a two-step approach. Over the years, we have found this approach is cost-effective for our clients, and it dramatically reduces the probability of failure to receive FDA clearance of a 510(k) submission.
Step 1: Pre 510(k) submission gap analysis and requirements evaluation
- The proposed intended use and design of your device help us determine the proper FDA product code and regulation number, which may point to device-specific guidance documents or required standards.
- We evaluate similar devices that already have FDA 510(k) clearance to determine whether any are suitable for use to determine substantial equivalence for your device. These are referred to as predicate devices.
- We provide a product-specific list of documents and information needed for the 510(k) submission.
- An assigned U.S. regulatory consultant will review the information to determine its suitability for the 510(k) submission.
- After evaluating this documentation, we prepare a detailed gap analysis report identifying incomplete or missing information required for a complete 510(k) submission.
Once you receive the comprehensive gap analysis, Emergo can help you close these "gaps" and will review additional information.
Step 2: Dossier compilation and FDA 510(k) submission
When all required documents and information have been received, Emergo will prepare your final 510(k) submission. We will:
- Prepare a technical comparison of your medical device to the predicate device(s).
- Prepare all 21 sections of the FDA 510(k) application.
- Submit the hard copy and eCopy of the 510(k) to the CDRH division within the FDA and be the correspondent for further communications with the FDA.
- Coordinate payment of FDA 510(k) submission fees on your behalf.
- Immediately communicate with you regarding all information received from the FDA following the 510(k) submission, and assist in addressing their requests for additional information, if applicable.
We want you to be successful introducing your device to the US market. As an FDA consulting firm for medical devices and IVD, we have successfully prepared and submitted FDA 510(k) submissions for medical device and IVD companies from around the world seeking to sell in the United States.
Will I receive a registration certificate after 510(k) clearance?
No. You will not receive a registration certificate after 510(k) clearance but the FDA will issue a 510(k) clearance letter and post it on their website. The website posting is your official proof that your device was cleared by the FDA.
How long is my 510(k) approval valid?
The 510(k) regulatory clearance is valid until you implement changes to the product, intended use, or indications for use. Changes must be assessed to determine if they warrant a new submission to the FDA.
If there is a predicate, do I have to do the same testing?
In general, you are required to do performance testing on your device, preferably as comparative testing with the known predicate. The test results must support the substantial equivalence of your product to the predicate.
Can a 510(k) be transferred to another company? Who owns it?
The company submitting the 510(k) is considered the owner of the 510(k). In some cases this may not be the manufacturer of the device. If the "owner" of the 510(k) is acquired, the the purchaser will list the device as part of their updated establishment registration, and that is considered sufficient to notify the FDA of a new owner and complete the transfer. If the manufacturing site changes, the company must validate the processes at the new site under the QMS and the new facility must be registered with the FDA.
What is considered a device family? What products can be in a single submission?
Devices that share the same FDA classification regulation/product code can often be “bundled” into a single submission. There are also times that devices with different product codes may be submitted in a single 510(k), if they are intended to be used together to perform the intended use of the 'family.'
For devices made outside the U.S., is home country approval required?
Home country approval is not required to receive FDA clearance.