Recently Issued Guidance Documents
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- Computer Software Assurance for Production and Quality Management System Software; Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, February 2026 - Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions; Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, February 2026 - Minimal Residual Disease and Complete Response in Multiple Myeloma: Use as Endpoints to Support Accelerated Approval; Draft Guidance for Industry
CDER/CBER/CDRH/OCE, January 2026 - Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products; Draft Guidance for Industry
CDER/CBER, January 2026 - Clinical Decision Support Software; Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER/CDER, January 2026 - Processes and Practices Applicable to Bioresearch Monitoring Inspections; Guidance for Industry
CDER/CBER/CDRH/CTP/CVM/OCP, December 2025 - Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices; Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, December 2025 - Enhancing Participation in Clinical Trials — Eligibility Criteria, Enrollment Practices, and Trial Designs; Guidance for Industry
CDER/CBER, December 2025 - Study of Sex Differences in the Clinical Evaluation of Medical Products; Draft Guidance for Industry
CDER/CBER/CDRH/OC, December 2025 - Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices; Guidance for Industry
CDER/CBER/CDRH/OCE, December 2025 - Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products - Questions and Answers; Guidance for Industry
CDER/CBER, December 2025 - eCopy Program for Medical Device Submissions; Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, December 2025 - QTc Information in Human Prescription Drug and Biological Product Labeling; Guidance for Industry
OCE/CDER/CBER, December 2025 - Cross-Center Master Files: Where to Submit; Draft Guidance for Industry
CDER/CBER/CDRH/CVM/OCP, November 2025