Common questions
When must we comply with FDA UDI requirements?
The FDA’s UDI rules will not be fully implemented until 2020, but Class III and Class II (higher-risk devices) are required to comply. The FDA is extending the UDI requirement for Class I (non CGMP exempt) and Unclassified Devices. Emergo can help you assess when you must be in compliance based on your device classification.
What is included in Emergo’s UDI training?
You will learn:
- Overview of regulation requirements for UDI
- What products require UDI number and the timeline for implementation
- Review of the FDA Quality System Regulations (QSR), i.e. 21 CFR 801, 820, 830
- Guidance on choosing an Issuing Agency for a UDI number
- Information required for the UDI
- Product labeling and packaging requirements
- Maintenance and changes to packaging
How do we determine the GMDN code for our product?
The UDI system requires the manufacturer to input the Global Medical Device Nomenclature (GMDN) Code within the GUDID database. If you have not determined the GMDN Code for your product(s), Emergo can assist with this process.
We will research the potentially suitable code descriptions (the code number and code term are only available once requested from the GMDN Agency), provide the results, and request a code from the database.
Additional services for United States:
- FDA認証(許可)取得のためのFDA 510(k)申請
- US FDA Form 483 and Warning Letter Analysis, Response, and Recovery
- FDA 510(k) Submission Consulting and Approval
- US FDA Consulting for Medical Device and IVD Manufacturers
- US FDA Medical Device Classification System
- FDA eMDR Adverse Event Reporting for Medical Device Companies
- US FDA Medical Device Establishment Registration
- US FDA Pre-Sub (Q-Sub) Consulting for Medical Devices
- FDA QSR Consulting
- FDA Submission for Medical Devices and In Vitro Diagnostics (IVDs)
- Human Factors Engineering (HFE) and Usability Testing for Medical Devices
- Consulting & Training for Medical Device Unique Device Identification (UDI) Requirements
- FDA US Agent Medical Devices in USA
- US FDA Official Correspondent for Medical Device Companies