[Federal Register Volume 60, Number 40 (Wednesday, March 1, 1995)]
[Notices]
[Pages 11105-11106]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-5061]



=======================================================================
-----------------------------------------------------------------------
[[Page 11106]]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 95D-0002]


Memorandum on the Use of an FDA Cleared or Approved Sterile 
Connecting Device in Blood Bank Practice; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of a memorandum dated August 5, 1994, to all registered 
blood establishments. In the August 5, 1994, memorandum, the Center for 
Biologics Evaluation and Research (CBER) recommends practices and 
procedures in the use of sterile connecting devices (STCD's). CBER also 
advises that certain uses of these devices may create a new product or 
significantly modify a regulated product, such that approval of a 
license application or an application supplement is required. This 
memorandum provides information to registered blood establishments on 
the use of STCD's.

DATES: Written comments may be submitted at any time.

ADDRESSES: Submit written requests for single copies of the memorandum 
to the Congressional and Consumer Affairs Branch (HFM-12), Food and 
Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. 
Send two self-addressed adhesive labels to assist that office in 
processing your requests. Persons with access to INTERNET may request 
this document from ``[email protected]''. The document may 
also be obtained by calling CBER FAX Information System at 301-594-1939 
from a FAX machine with a touch tone phone attached or built in. Submit 
written comments on the memorandum to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857. Two copies of any comments are to be submitted, 
except that individuals may submit one copy. Requests and comments 
should be identified with the docket number found in brackets in the 
heading of this document. The memorandum and received comments are 
available for public examination in the Dockets Management Branch 
(address above) between 9 a.m. and 4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Betty J. Poindexter, Center for 
Biologics Evaluation and Research (HFM-335), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-496-
2577.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
memorandum to all registered blood establishments on the use of an FDA 
cleared or approved STCD. STCD's produce sterile welds between two 
pieces of compatible tubing. This procedure permits sterile connection 
of a variety of containers and/or needles. This document describes 
recommended practices and procedures for the use of these devices.
    The memorandum provides guidance on the common uses of STCD's as 
follows: (1) Adding a new or smaller needle to a blood collection set; 
(2) preparing components; (3) pooling blood products; (4) preparing an 
aliquot for pediatric use and divided units; (5) connecting additional 
saline or anticoagulant lines during an automated plasmapheresis 
procedure; (6) attaching processing solutions; (7) adding an FDA-
cleared leukocyte reduction filter; and (8) removing samples from blood 
product containers for testing.
    The memorandum also presents general guidance as well as specific 
information and examples concerning specifications for submission of 
applications and application supplements to FDA addressing the use of a 
STCD. It also includes an appendix with the currently approved dating 
periods for blood components and source plasma (21 CFR 610.53) and 
currently recommended dating periods for automated plateletpheresis 
products (see Revised Guideline for Collection of Platelets, Pheresis 
(54 FR 3852, January 26, 1989)).
    As with other memoranda, FDA does not intend this document to be 
all-inclusive and cautions that not all information may be applicable 
to all situations. The memorandum is intended to provide information 
and does not set forth new requirements. The procedures cited in the 
memorandum are recommendations. FDA anticipates that blood 
establishments may develop alternative procedures and discuss them with 
FDA. FDA may find those alternative procedures acceptable. FDA 
recognizes that advances may continue in the use of STCD's and that 
this document may become outdated as those advances occur. The 
memorandum does not bind FDA and does not create or confer any rights, 
privileges, or benefits on or for any private person, but is intended 
merely for guidance.
    Interested persons may, at any time, submit to the Dockets 
Management Branch (address above) written comments on the memorandum. 
Two copies of any comments are to be submitted, except that individuals 
may submit one copy. Comments are to be identified with the docket 
number found in brackets in the heading of this document. Received 
comments may be seen in the Dockets Management Branch between 9 a.m. 
and 4 p.m., Monday through Friday.
    Received comments will be considered in determining whether further 
revisions to the memorandum are warranted.

    Dated: February 17, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-5061 Filed 2-28-95; 8:45 am]
BILLING CODE 4160-01-F