[Federal Register Volume 78, Number 58 (Tuesday, March 26, 2013)]
[Notices]
[Pages 18353-18354]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-06865]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-D-0069; (Formerly FDA-2007D-0393)]
Guidance for Industry: Blood Establishment Computer System
Validation in the User's Facility; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a document entitled ``Guidance for Industry: Blood
Establishment Computer System Validation in the User's Facility'' dated
April 2013. The guidance document provides assistance to blood
establishments in developing a blood establishment computer system
validation program, consistent with recognized principles of software
validation, quality assurance, and current good software engineering
practices. The guidance announced in this document finalizes the draft
guidance of the same title dated October 2007.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for single copies of the guidance to
the Office of Communication, Outreach and Development (HFM-40), Center
for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist the office in
processing your requests. The guidance may also be obtained by mail by
calling CBER at 1-800-835-4709 or 301-827-1800. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.
Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-
[[Page 18354]]
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Melissa Reisman, Center for Biologics
Evaluation and Research (HFM-17), Food and Drug Administration, 1401
Rockville Pike, Suite 200N, Rockville, MD 20852-1448, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a document entitled
``Guidance for Industry: Blood Establishment Computer System Validation
in the User's Facility '' dated April 2013. The guidance document
provides assistance to blood establishments in developing a blood
establishment computer system validation program, consistent with
recognized principles of software validation, quality assurance, and
current good software engineering practices. The guidance document
describes the requirements in Title 21 Code of Federal Regulations that
apply to blood establishment validation of systems, and FDA's
recommendations for the validation of systems. While the guidance may
provide manufacturers of blood establishment computer software (BECS)
with information about validation of computer systems in the user's
facility, the guidance does not address the software manufacturer's
validation responsibilities or the submission of a 510(k) premarket
notification for BECS.
In the Federal Register of October 29, 2007 (72 FR 61171), FDA
announced the availability of the draft guidance of the same title
dated October 2007. FDA received several comments on the draft guidance
and those comments were considered as the guidance was finalized. In
addition, editorial changes were made to improve clarity. The guidance
announced in this notice finalizes the draft guidance dated October
2007.
The guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents FDA's
current thinking on this topic. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR 606.100(b) and 606.160 have been
approved under OMB control number 0910-0116. The collections of
information in 21 CFR 211.68 and 211.100 have been approved under OMB
control number 0910-0139.
III. Comments
Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov
IV. Electronic Access
Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.
Dated: March 21, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-06865 Filed 3-25-13; 8:45 am]
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