The following question was asked during the “Ask the FDA” session (326-QE) on 10/25/04 at the AABB Annual Meeting held in Baltimore, MD as reported by SoftwareCPR Partner Molly Ray:
When blood establishment computer software manufacturers distribute their device (software) for beta testing, they are required to label the software in accordance with the IDE regulations in 21 CFR 812. Under what circumstances would a blood establishment computer software manufacturer have to comply with the additional IDE regulations in 21 CFR 812, e.g., IRB, informed consent, etc.?
Sheryl Kochman, the Biologic Devices Branch Chief in the Division of Blood Applications in CBER, provided the answer that the additional IDE regulations would only be applicable to the beta testing if the software was used as the test of record.