“Letter to Manufacturers of Prescription Home Monitors for Non-Stress Tests”
This letter was issued September 6, 1996. This letter notified manufacturers of perscription home monitors of non-stress tests being used by pregnant women that devices could be cleared via the 510(k) process from this point forward in lieu of a premarket approval process.
Attached to this letter is a document entitled “Explanation for Items in DRAERD Premarket Notification 510(k) Screening Checklist” and this is dated February 6, 1996.
Section 8 of this document discusses software information and mentions hardware verification validation as well. It also references the now obsolete 1991 software submission guidance, “Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review,” and the current guidance entitled, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices,” should be referenced in its place. Item 8 excerpted from the guidance document is repeated below:
“A report on software/firmware requirements, development, validation and verification is needed for all computer controlled devices dependent on software. A software release number should be indicated. Hardware validation and verification may also be required. The appropriate testing information should be submitted. This information is contained in Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review. ”