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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Blood Establishment Computer Software: Understanding What to Include in a 510(k) Submission; Public Workshop

November 4, 2009
8:30 a.m. – 5:00 p.m.

November 5, 2009
8:30 a.m. – 12:00 p.m.

Workshop Goals and Objectives

The Food and Drug Administration (FDA) held a public workshop entitled “Blood Establishment Computer Software:  Understanding What to Include in a 510(k) Submission.”  The purpose of the public workshop 2s 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 510k submission.   The public workshop featured presentations and panel discussions led by FDA and other experts in software quality engineering.   

Blood establishment computer software 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, including premarket notification pursuant to section 510(k) of the Act (21 U.S.C. 360(k)) and applicable regulations at 21 CFR 807 Subpart E.  The workshop consisted of a series of presentations, question and answer sessions, and a panel discussion on the following topics: (1) the history and legal framework of BECS regulation in the United States; (2) content of 510(k) submissions, applicable regulations, and guidance; (3) common challenges in obtaining 510(k) clearance; (4) FDA recognized software standards; (5) general software quality engineering; (6) transfusion safety management systems (blood administration software); (7) virtualization; and (8) wireless technology.  


The Universities at Shady Grove Conference Center
Building II, Multipurpose Room
9630 Gudelsky Drive
Rockville, MD 20850 


Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002