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medical software

CLIENT ALERT: FDA Pilot Program Seeking Software Developers

CLIENT ALERT: FDA Pilot Program Seeking Software Developers

The U.S. Food and Drug Administration is currently accepting requests from medical software developers to participate in a precertification pilot program that is scheduled to begin September 1, 2017.  The program is aimed at developing precertification criteria for software companies that would allow approved companies to engage in a streamlined premarket review process for certain digital health products.  The FDA will accept up to nine participants for the pilot program, which the Agency says will include both large, established software developers and small startup companies.