Federal Register Notice: FDA will hold a public workshop 11/4-5 entitled “Blood Establishment Computer Software: Understanding What to Include in a 510(k) Submission.” The workshop will aim to educate industry on the laws and regulations for medical devices that are applicable to Blood Establishment Computer Software, including requirements for the content of a 510(k) submission. It will feature presentations and panel discussions led by FDA and other experts in software quality engineering. The workshop will be held 11/4, from 8:30 a.m. to 5 p.m. and 11/5, from 8:30 a.m. to 12 noon at The Universities at Shady Grove Conference Center, Bldg. II, multipurpose room, 9630 Gudelsky Dr., Rockville, MD 20850. Contact Rhonda Dawson, (301) 827-6129. To view this notice, click here.