CSMS Message: 06-000088

TO: ALL ABI FILERS

FROM: THE FOOD & DRUG ADMINISTRATION

SUBJECT: TWO NEW FDA AFFIRMATION OF COMPLIANCE (AOC) CODES
(THIS IS A RE-ISSUE OF ADMINISTRATIVE MESSAGE 06-0042
THIS MESSAGE CONTAINS THE CORRECT AOC'S)

FDA HAS ADDED TWO NEW AFFIRMATION OF COMPLIANCE (AOFC) CODES
WHICH CAN BE USED WHEN ENTRY INFORMATION IS TRANSMITTED FOR
HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS
(HCT/PS) REGULATED SOLELY UNDER SECTION 361 OF THE PHS ACT AND
21 CFR 1271. THE NEW A OF C CODES ARE HCT AND HRN.

PRODUCTS REGULATED AS HCT/PS INCLUDE ARTICLES CONTAINING OR
CONSISTING OF HUMAN CELLS, OR TISSUES THAT ARE INTENDED FOR
IMPLANTATION, TRANSPLANTATION, INFUSION, OR TRANSFER INTO A
HUMAN RECIPIENT.

WITH TRANSMISSION OF THE NEW AOFC CODES, THE FILER AFFIRMS THE
PRODUCT IDENTIFIED IN THE FDA LINE MEETS THE REGULATORY
REQUIREMENTS SPECIFIC TO THE CODE. WHILE ELECTRONIC SUBMISSION
OF THIS INFORMATION IS VOLUNTARY, TRANSMISSION OF THE DATA CAN
GREATLY EXPEDITE INITIAL SCREENING AND FURTHER FDA REVIEW OF AN
ENTRY. THE MANUFACTURER, SHIPPER, OR IMPORTER OF RECORD SHOULD
BE ABLE TO INDICATE WHEN THESE AFFIRMATIONS SHOULD BE USED AND
SUPPLY THE QUALIFIER INFORMATION WHEN REQUIRED.

AOFC CODES SPECIFICS:

HCT = HUMAN CELLS, TISSUES AND CELLULAR AND TISSUE-BASED
PRODUCTS...NOW HCT = HCT/P COMPLIANT

THIS AFFIRMATION SHOULD BE USED TO INDICATE THE HCT/PS BEING
IMPORTED OR OFFERED FOR IMPORT ARE IN COMPLIANCE WITH ALL
APPLICABLE REQUIREMENTS OF 21 CFR 1271. NO QUALIFIER IS
REQUIRED WHEN THIS AOFC CODE IS TRANSMITTED.

HRN = HUMAN CELLS, TISSUES AND CELLULAR AND TISSUE-BASED
PRODUCT ESTABLISHMENT REGISTRATION NUMBER...NOW HRN = HCT/P
REGISTRATION NUMBER.

THE QUALIFIER REQUIRED WITH USE OF THIS AFFIRMATION SHOULD BE
THE HCT/P ESTABLISHMENT REGISTRATION NUMBER ISSUED BY FDA'S
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER) FOR THE
FIRM MANUFACTURING THE PRODUCT IDENTIFIED IN THE FDA LINE.
MOST FOREIGN MANUFACTURERS OF BIOLOGIC PRODUCTS ARE REQUIRED TO
REGISTER AND SUBMIT A LIST OF EVERY HCT/P MANUFACTURED (21 CFR
1271.21), EXCEPT THOSE EXEMPT FROM REGISTRATION UNDER 21 CFR
1271.15. FOR EXAMPLE, INDIVIDUALS (SUCH AS PHYSICIANS) ARE NOT
REQUIRED TO REGISTER OR LIST IF THEY ARE UNDER CONTRACT,
AGREEMENT, OR OTHER ARRANGEMENT WITH A REGISTERED ESTABLISHMENT
AND ENGAGED SOLELY IN RECOVERING TISSUE.

IF YOU HAVE QUESTIONS ABOUT WHETHER AN IMPORTED HCT/P MEETS THE
CRITERIA LISTED IN 21CFR 1271.10(A), CALL CBER, OCBQ, DIVISION
OF CASE MANAGEMENT, AT 301-827-6201.