The in silico analysis your special controls name by method
Across a growing set of molecular device classifications, FDA requires a documented protocol for the continuous monitoring, identification, and handling of genetic mutations and novel isolates or strains — naming regular literature review and periodic in silico analysis of target sequences as the method. The requirement appears in 21 CFR 866.3981, in 866.3982, and in classifications finalized as recently as mid-2026.
Three obligations follow, and they're the ones teams underestimate:
All results must be documented. Not just the findings that mattered. The runs that came back clean are part of the record.
FDA may request further analysis on a 48-hour clock. Nobody starts a manual alignment exercise when that request arrives and finishes in two days with something defensible.
Findings indicating impact on stated device performance are immediately reportable. Which means the impact call itself needs to be documented and explainable, not just reached.
BLASTseq AI executes the protocol and produces the record in the same run.
Every hit is evaluated on sequence identity, mismatch location impact, and hybridization ΔG°T. The contributing factors are shown with the composite call, and the exported record includes the reference-database release, search date, query sequences, and scoring parameters.