Recently Posted Guidance Documents on Drugs, Devices, Safety, ICH-Efficacy, Administrative/Procedural

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Physical Medicine Devices, Premarket 4/16/2018 Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices - Guidance for Industry and Food and Drug Administration Staff Premarket, Emerging Technology, Molecular and Clinical Genetics Devices, IVDs (In Vitro Diagnostic Devices) 4/13/2018  Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics - Guidance for Stakeholders and Food and Drug Administration Staff 4/13/2018 Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing (NGS) - Based In Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis of Suspected Germline Diseases - Guidance for Stakeholders and Food and Drug Administration Staff Premarket, Special Controls Document 4/12/2018  Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria - Draft Guidance for Industry and Food and Drug Administration Administrative / Procedural 4/12/2018  Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination Guidance for Industry 4/12/2018  Special Protocol Assessment Guidance for Industry Safety 4/11/2018 Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic ICH-Efficacy 4/10/2018  E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population