Common US FDA consulting questions
Who owns a 510(k) premarket clearance? Can ownership be transferred?
The person who possesses the premarket clearance for a device is considered the 510(k) holder. If a 510(k) premarket clearance is sold or otherwise transferred to another entity, the FDA is notified via compliance with annual device listing requirements.
How long is my 510(k) premarket clearance valid?
An FDA 510(k) premarket clearance is valid until changes are made to the device that could either significantly affect its safety or effectiveness, or its intended use. Changes need to be assessed to determine if a new 510(k) submission to the FDA is warranted.
Can multiple medical devices be included in a single submission?
Devices that share the same FDA classification regulation/product code can often be “bundled” into a single regulatory submission.
Additional services for United States:
- Consulting & Training for Medical Device Unique Device Identification (UDI) Requirements
- FDA 510(k) Submission Consulting and Approval
- 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 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