Unpacking Averages: Assessing the Products Included in FDA’s Voluntary Malfunction Summary Reporting Program

At the end of 2022, FDA published a draft guidance on Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers. The draft guidance explains several aspects of the VMSR Program, including FDA’s approach to determining the eligibility of product codes for the program….
By: Epstein Becker & Green