IN LIMBO ON THE BORDER – by Glen Feye
FDA is the main gatekeepers for foreign Medical Devices and Drugs imported into the United States.
If your shipment is questioned by FDA and receive a “Notice of FDA Action” contact your US Agent and you may need a FDA Compliance Consultant .
If your shipment is non compliant- expect “HOLD DESIGNATED”
If the appropriate action is not taken in a timely manner- expect ” REFUSAL OF ADMISSION”
FDA wants these products out of the country or distroyed in a timely manner
1) Letter of Authorization
All FDA communications must include the Entry Number
If you are working with a third-party consultant – FDA requires a Letter of Authorization from firm
2) Current FDA Registration and Device Listing-
Note-This is an annual process- and medical devices manufacturers must pay the appropriate User Fee by the beginning of the upcoming year
3) Regulatory Status- Devices and Drugs
Define product mix. Develop a comprehensive spreadsheet which defines the following:
Devices-
Define device classification based on intended use of device as well as the appropriate product code and device listing
Identify 510k or PMA number(s)
Device accessories are devices
Components are not devices
Drug
Define drug based, – obtain the NDC numbers.
Navigating through this process and getting proper communication with FDA is challenging.
Contact www.accuratefdaconsulting.com or call a FDA Consultant to get help to properly remediate these import complications