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

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) 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 510k submission. The public workshop will feature 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 will consist 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.

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

*Please visit http://www.shadygrove.umd.edu/about/directions/ for directions, visitor parking and public transportation.

Registration
There is no registration fee for the workshop. Early registration is recommended before October 16, 2009, as seating is limited. Registration on the day of the workshop will be provided on a space available basis beginning at 7:30 a.m. To register, complete the attached registration form in this announcement and mail, fax or e-mail it to Rhonda Dawson, Food and Drug Administration, HFM-302, 1401 Rockville Pike, Rockville, MD 20852; Fax: 301-827-2843; E-mail: rhonda.dawson@fda.hhs.gov Registrants will receive an e-mail confirmation.

If you need special accommodations due to a disability, please contact Rhonda Dawson at least seven days in advance of the workshop.

Overnight Accommodations
Participants requiring overnight accommodations can contact one of the following hotels.

These hotels offers shuttle bus service to the Universities at Shady Grove Conference Center.

Crowne Plaza
3 Research Court
Rockville, MD 20850
(301) 840-0200

Woodfin Suites Hotel
1380 Piccard Drive
Rockville, MD 20850
(301) 590-9880

Comfort Inn Shady Grove
16216 Frederick Road
Gaithersburg, MD 20877
(301) 330-0023

Residence Inn by Marriott
9721 Washington Blvd.
Gaithersburg, MD 20878
(301) 590-3003

Holiday Inn Gaithersburg
2 Montgomery Village Avenue
Gaithersburg, MD 20879
(301) 948-8900

Contact Person
Rhonda Dawson
Program Coordinator
Food and Drug Administration
Office of Blood Research & Review
Center for Biologics Evaluation and Research
1401 Rockville Pike, HFM-302
Rockville, MD 20852
Phone: 301-827-6129
Fax: 301-827-2843
e-mail: rhonda.dawson@fda.hhs.gov

ABRIR AQUÍ para acceder al documento FDA:
Blood Establishment Computer Software: Understanding What to Include in a 510(k) Submission; Public Workshop