With the FDA’s Technical Rejection Criteria now enforceable, avoiding automated SEND dataset rejection starts with understanding the rules, and applying them correctly.
SEND’s flexibility is both its strength and challenge; verification reveals that while quality is improving, consistency remains key to making standardized data truly usable.
SEND may seem dry to outsiders, but for those immersed in it, it’s a passion, fueling precision, efficiency, and a shared dedication to getting it right.
SEND’s flexibility allows broad adoption, but as a vendor, I can’t help wishing it were more rigid. Consistency would make tools easier to build and data easier to compare.
Despite being a standard, SEND’s flexibility means everyone does it slightly differently, making it a “subjective standard” in practice.
In a digital world where speed is expected SEND still takes time, because quality, compliance, and subjective interpretation demand more than just pressing “convert.”
