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U.S. Food and Drug Administration Kicks Off Fall with Several Impactful Medical Product Guidances | Wilson Sonsini Goodrich & Rosati - Vimarsana News

U.S. Food and Drug Administration Kicks Off Fall with Several Impactful Medical Product Guidances | Wilson Sonsini Goodrich & Rosati

The U.S. Food and Drug Administration (FDA) is making efforts to modernize both the 510(k) approval process for medical devices and study designs for drugs and biologics.

Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" - Vimarsana News

Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"

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.

Source: fda.gov