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“Since issuing the action plan, we have partnered with a range of digital health software companies and other stakeholders to begin developing a precertification program that could replace the need for a premarket submission for certain medical software products and allow for a streamlined review of marketing submissions for others. While there is general consensus that the FDA needs a new process, exactly how the changes would be implemented is unclear.  “At the end of the day this is an exchange of responsibility. What we are talking about is


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