This FDA CDRH guidance document provides recommendations for the content and submission of human factors information in premarket medical device applications including 510(k) and PMA submissions. The guidance specifies required usability engineering documentation based on applicable standards such as IEC 62366-1, risk analysis methodologies, labeling safety considerations, and validation evidence. It establishes expectations for human factors evaluation data components to support FDA's regulatory review of device safety and effective use in intended user populations and use environments.

FDA CDRH provides comprehensive FAQs addressing regulatory classification and oversight of clinical decision support software (CDSS). The guidance clarifies distinctions between software qualifying as a medical device under FDA jurisdiction versus informational tools falling outside regulatory scope. Key topics include risk assessment methodologies, software development and validation requirements aligned with IEC 62304 standards, cybersecurity considerations, and clinical effectiveness evaluation. This reference document serves as essential regulatory interpretation for manufacturers developing CDSS and healthcare IT professionals navigating FDA's evolving software oversight framework.

The FDA CDRH remains vigilant in ensuring the reliability of data submitted in support of medical device submissions. The Agency has determined that CCIC Huatongwei International Inspection (Suzhou) Co., Ltd. generated false, copied, or otherwise invalid test data submitted to FDA across multiple studies. Consequently, all study data from this testing facility will be rejected until the firm adequately addresses these data integrity issues. Device manufacturers and sponsors are reminded to conduct rigorous evaluation and oversight of third-party testing facilities to ensure compliance with FDA data integrity standards and Good Laboratory Practice requirements.