Document ID: FDA-2009-N-0664-0079
Agency: fda
Document Type: Notice
Title: Blood Establishment Computer Software: Understanding What to Include in a 510(k) Submission; Public Workshop
Posted Date: 2009-08-28T04:00Z

[Federal Register: August 28, 2009 (Volume 74, Number 166)]
[Notices]               
[Page 44374-44375]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28au09-62]                         

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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: rhonda.dawson@fda.hhs.gov.
    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