Addressing FDA Import Alert and “Notice of FDA Action”

Posted By on Jun 17, 2015 | 4 comments


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

4 Comments

  1. Devices must meet FDA regulations prior to the importation of medical devices into the United States.

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    • That is correct. 510k and PMA if required. FDA Registration and Device Listing. Plus the finished device must meet the appropriate 21 CFR Part 820 (QSR), 803, and 806 requirements

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  2. Import Alert 99-30 authorizes FDA districts to automatically detain any product from China that contains milk or milk-based ingredients,

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    • Hi! Correct. Thank you for your comment. BTW Accurate Consultants specializes FDA regulations regarding medical devices, IVDs, biologics, pharmaceuticals and combinations thereof. Foods are outside of our scope.

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