CSMS Message: 00-000467

TO: ALL ABI FILERS

FROM: FOOD AND DRUG ADMINISTRATION

THE FDA IS ANNOUNCING AN UPDATE TO THE USE OF THEIR AFFIRMATION OF
COMPLIANCE CODE 'LWC'. THIS CODE SHOULD BE TRANSMITTED TO FDA WHEN
IMPORTING ANY PATIENT-CONNECTED ELECTRODE LEAD WIRES OR PATIENT CABLES OR
ANY DEVICES THAT USE THEM. THE AFFIRMATION MEANS THAT EITHER (1) THE
DEVICE SHIPMENT DOES NOT CONTAIN ANY PRE-WIRED ELECTRODES, ELECTRODE LEAD
WIRES OR PATIENT (TRANSDUCER) CABLES, OR (2) ANY PRE-WIRED ELECTRODES,
ELECTRODE LEAD WIRES OR PATIENT CABLES THAT COMPLY WITH 21 CFR 898,
PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES.

THE REFERENCED REGULATION AND PERFORMANCE STANDARD INITIALLY APPLIED
TO ELECTRODE LEAD WIRES AND PATIENT CABLES THAT ARE USED WITH TEN TYPES
OF MEDICAL DEVICES. AS OF MAY 9, 2000, THE PERFOMANCE STANDARD IS
EXTENDED TO COVER ALL PATIENT-CONNECTED ELECTRODE LEAD WIRES AND PATIENT
CABLES USED WITH ANY ANY MEDICAL DEVICE (APPROXIMATELY 125 ADDITIONAL
DEVICE TYPES). THE LWC A OF C CODE CAN BE TRANSMITTED FOR THOSE
ADDITIONAL PRODUCTS EFFECTIVE MAY 9, 2000. IF THE A OF C CODE IS NOT
TRANSMITTED ELECTRONICALLY AFTER THAT DATE, FDA MAY REQUEST DOCUMENTATION
INDICATING PROOF OF COMPLIANCE WITH THE PERFORMANCE STANDARD. FAILURE TO
RESPOND TO THE DOCUMENT REQUEST MAY RESULT IN FDA DETENTION WITHOUT
PHYSICAL EXAM OF THE PRODUCT. FILERS' CLIENTS WHO IMPORT MEDICAL DEVICES
ARE THE BEST SOURCE TO DETERMINE IF THE A OF C APPLIES AND WHEN FURTHER
COMPLIANCE DOCUMENTATION SHOULD BE AVAILABLE FOR FDA REVIEW. FILERS CAN
PROVIDE THEIR CLIENTS WITH THE FOLLOWING INFORMATION:

FOR QUESTIONS ABOUT THE PERFORMANCE STANDARD, PLEASE CONTACT STEWART
CRUMPLER IN FDA'S CENTER FOR DEVICES AND RADIOLOGICAL HEALTH, AT
301-594-4659 OR VIA FAX AT 301-594-4672. INFORMATION IS ALSO AVAILABLE
ON THE CDRH WEB SITE AT WWW.FDA.GOV/CDRH/OCHOME.HTML.