FDA issued a final guidance entitled “Cardiac Allograft Gene Expression Profiling Test Systems”.
Section 4 Risks to Health identifies 2 classes of risks and references mitigation measures listed in other sections.
Section 5. C. Requests detailed descriptons of the algroithms used to determine the probability of actute cellurlar rejection including datsets used to validate the alorithms.
Section 5. D. requests example test reports generated for clinicians since one concern is the ease of interpretation and completeness of the information.
Section 7 addresses Software specifically. In addition to referring to the general software submission guidances, it references 14971 and AAMI SWhk and it states that usually the LOC is Moderate and then requests:
– a full description of software design
– states utilities should not be included beyond the specific intended use
– hazard analysis including ways signal analysis, data storage, commuincations, and cybersecurity relate to hazards and risk
– validation documentation of the compatibility of assay software with instrumentation software
-If the information you include in the 510(k) is based on a version other than the release version, identify all differences in the 510(k) and detail how these differences (including any unresolved anomalies) impact the safety and effectiveness of the device.