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FDA’s Jan 7, 2025 draft for AI-enabled device software functions recommends including: model description, dataset lineage/partitions and representativeness, performance metrics tied to claims, bias analysis/mitigation, human-AI use, postmarket monitoring, and (if you’ll update) a PCCP. Package these in the Software (DSF) and related sections of eSTAR (510(k) now; De Novo eSTAR mandatory Oct 1, 2025) Why AI/ML Documentation Matters Now With AI-driven Software as a Medical Devi

Starting October 1, 2025, all De Novo requests for SaMD must be submitted using the FDA’s eSTAR template. This shift brings new module requirements tailored to software, including design documentation, cybersecurity, verification/validation, and AI lifecycle controls. If you're preparing a SaMD De Novo, this format isn’t optional—it’s the new standard. What Is eSTAR? eSTAR stands for Electronic Submission Template and Resource. It’s a structured, interactive PDF the FDA devel

“For purposes of this guidance, FDA refers to a software function that meets the definition of a device as a ‘device software function.’” (FDA Jan 7, 2025 draft). In practice, DSF covers both stand-alone software (SaMD) and software in a device (SiMD). If a software function has a medical intended use under FD&C §201(h), it’s a DSF and falls under FDA oversight. Why This Term Matters for AI Teams? SaMD has been the headline for years, but the AI draft guidance shifts focus to

An FDA import alert flags products/firms that appear to violate the law and allows detention without physical examination (DWPE) ....

An FDA warning letter is a public notice that a company significantly violated medical device regulations. Common triggers include QMS...

Navigating the complex waters of regulatory compliance has long been a challenge for businesses across the globe. As the volume and...