Important FDA Guidance Documents

If you are preparing for a regulatory submission to the US Food and Drug Administration (FDA), please consult the following list of guidance documents relevant to focused ultrasound. Please note that this list was provided to the Foundation by staff at the FDA and may not represent a complete list of relevant documents.

• Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions
• Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics
• Clinical Investigations for Prostate Tissue Ablation Devices
• Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions
• Establishment and Operation of Clinical Trial Data Monitoring Committees
• Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies
• Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions
• Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications
• General Wellness: Policy for Low Risk Devices
• Humanitarian Device Exemption (HDE) Program
• Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies
• Least Burdensome Provisions: Concept and Principles
• Office of Science and Engineering Laboratories (OSEL) Therapeutic Ultrasound Program email
• Principles of Premarket Pathways for Combination Products
• Reporting of Computational Modeling Studies in Medical Device Submissions
• Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
• Significant Risk and Nonsignificant Risk Medical Device Studies
• Therapeutic Ultrasound Program: Research on Therapeutic Ultrasound Medical Devices
• Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
• FDA Guidance Document: Marketing Clearance of Diagnostic Ultrasound Systems and Transducers
• Focused Ultrasound Stimulator System for Aesthetic Use – Class II Special Controls Guidance for Industry and FDA Staff
• Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters – Guidance for Industry
• Content of Premarket Notifications (510(k)s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi – Guidance for Industry and for FDA Reviewers
• Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions – Draft Guidance for Industry and Food and Drug Administration Staff
• Reporting of Computational Modeling Studies in Medical Device Submissions – Guidance for Industry and Food and Drug Administration Staff