Common Questions
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.
Additional services for United States:
- Consulting & Training for Medical Device Unique Device Identification (UDI) Requirements
- FDA eMDR Adverse Event Reporting for Medical Device Companies
- FDA QSR Consulting
- FDA Submission for Medical Devices and In Vitro Diagnostics (IVDs)
- FDA US Agent Medical Devices in USA
- FDA認証(許可)取得のためのFDA 510(k)申請
- Human Factors Engineering (HFE) and Usability Testing for Medical Devices
- US FDA Consulting for Medical Device and IVD Manufacturers
- US FDA Form 483 and Warning Letter Analysis, Response, and Recovery
- US FDA Medical Device Classification System
- US FDA Medical Device Establishment Registration
- US FDA Official Correspondent for Medical Device Companies
- US FDA Pre-Sub (Q-Sub) Consulting for Medical Devices