E9-20781. 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.

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: [phone], e-mail: [e-mail].

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, 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.