[Federal Register Volume 74, Number 166 (Friday, August 28, 2009)]
[Notices]
[Pages 44374-44375]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-20781]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0664]
Blood Establishment Computer Software: Understanding What to
Include in a 510(k) Submission; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
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The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Blood Establishment Computer Software:
Understanding What to Include in a 510(k) Submission.'' The purpose of
the public workshop is to educate industry on the laws and regulations
for medical devices that are applicable to Blood Establishment Computer
Software (BECS), including requirements for the content of a 510(k)
submission. The public workshop will feature presentations and panel
discussions led by FDA and other experts in software quality
engineering.
Date and Time: The public workshop will be held on November 4,
2009, from 8:30 a.m. to 5 p.m. and November 5, 2009, from 8:30 a.m. to
12 noon.
Location: The public workshop will be held at The Universities at
Shady Grove Conference Center, Bldg. II, multipurpose room, 9630
Gudelsky Dr., Rockville, MD 20850.
Contact Person: Rhonda Dawson, Center for Biologics Evaluation and
Research (HFM-302), Food and Drug Administration, 1401 Rockville Pike,
suite 550N, Rockville, MD 20852-1448, 301-827-6129, FAX: 301-827-2843,
e-mail: [email protected].
Registration: Mail, fax, or e-mail your registration information
(including name, title, firm name, address, telephone, and fax numbers)
to the contact person by October 16, 2009. There is no registration fee
for the public workshop. Early registration is recommended because
seating is limited. Registration on the day of the public workshop will
be provided on a space available basis beginning at 7:30 a.m.
If you need special accommodations due to a disability, please
contact Rhonda Dawson (see Contact Person) at least 7 days in advance.
SUPPLEMENTARY INFORMATION: BECS is a device used in the prevention of
disease in humans, by identifying unsuitable donors and preventing the
release of infectious or otherwise harmful blood and blood components
for transfusion or for further manufacturing use. Facilities that
manufacture and distribute BECS are subject to device provisions of the
Federal Food, Drug, and Cosmetic Act (the act), including premarket
notification under section 510(k) of the act (21 U.S.C. 360(k)) and
applicable regulations at 21 CFR 807, subpart E. The public workshop
will consist of a series of presentations, question-and-answer
sessions, and a panel discussion on the following topics:
The history and legal framework of BECS regulation in the
United States;
Content of 510(k) submissions, applicable regulations, and
guidance;
Common challenges in obtaining 510(k) clearance;
FDA-recognized software standards;
General software quality engineering;
Transfusion safety management systems (blood
administration software);
Virtualization; and
Wireless technology.
Transcripts: Transcripts of the public workshop may be requested in
writing from the Freedom of Information Office (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857,
[[Page 44375]]
approximately 15 working days after the public workshop at a cost of 10
cents per page. A transcript of the public workshop will be available
on the Internet at http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/TranscriptsMinutes/default.htm.
Dated: August 21, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-20781 Filed 8-27-09; 8:45 am]
BILLING CODE 4160-01-S