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Institutional Review Board (IRB) Review of Individual Patient Expanded Access Submissions for Investigational Drugs and Biological Products
Final Guidance for Industry and FDA Staff, Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development
This guidance provides clarification and updated information on the use of ISO 10993-1 to support PMAs, HDEs, IDE Applications, 510(k)s, and De Novo requests.
Administrative/Procedural Guidance
This guidance provides a policy to expand the availability of face masks and barrier face coverings during the COVID-19 pandemic.