| Title: | FDA: TWO NEW AFFIRMATION OF COMPLIANCE CODES |
|---|---|
| Date: | 1998-08-12 |
| To: | abi |
| Links: | previous, next |
TO: ALL AUTOMATED FILERS USING THE FDA INTERFACE
TWO NEW AFFIRMATION OF COMPLIANCE (A OF C) CODES HAVE BEEN ADDED TO
THE FDA INTERFACE/OASIS AND ARE AVAILABLE FOR IMMEDIATE USE AND CAN BE
QUERIED THROUGH THE ABI 'OP' TRANSACTION.
LWC IS THE A OF C CODE TO USE WHEN A SHIPMENT IS SUBJECT TO AND COMPLIES
WITH THE PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES,
21 CFR 898, EFFECTIVE 5/98. NO A OF C QUALIFIER IS REQUIRED.
SIF IS THE A OF C USED TO IDENTIFY THE IMPORTER (U.S. OWNER OR U.S.
CONSIGNEE) AS IDENTIFIED IN 21 CFR 123.3 OF SEAFOOD HACCP REGULATED
PRODUCTS. THE QUALIFIER REQUIRED WITH TRANSMISSION OF THIS CODE IS THE
FDA FIRM ESTABLISHMENT IDENTIFIER (FEI) NUMBER FOR THE FIRM.
ADDITIONAL INFORMATION ABOUT THESE NEW CODES IS PROVIDED IN THE LATEST
VERSION OF THE A OF C DOCUMENT WHICH IS AVAILABLE FROM THE FDA IMPORT
PROGRAM MANAGER IN YOUR AREA.
TRADE SUPPORT, U.S. CUSTOMS
DIVISION OF IMPORT OPERATIONS AND POLICY, FDA