| Title: | FDA Import Entry Review Process - Affirmations of Compliance |
|---|---|
| Date: | 2011-09-08 |
| To: | abi |
| Links: | previous, next |
To: ABI Filers
Subject: FDA Import Entry Review Process - Affirmations of Compliance
The United States Food and Drug Administration (USFDA), Center for Devices and Radiological Health (CDRH), has issued a follow up letter to their March 24, 2011, Letter to Industry about Import Entry Review Process. The purpose of the September 6, 2011, follow up letter is to provide specific recommendations to facilitate the import entry review process for medical and non-medical radiation emitting electronic products. These recommendations will directly impact your company's ability to import medical and non-medical radiation emitting electronic products, electronic product components, parts and finished product into the US.
The USFDA is attempting to help expedite the admissibility process for submissions that contain the correct Affirmations of Compliance (AofC) and other requested data. If appropriately submitted, this practice will increase the likelihood that your shipment may be processed based on import system screening and not held for further USFDA entry review.
The September 6, 2011, Letter to Industry about Import Entry Review Process is available at:
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm271180.htm.