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FDA's second draft Pre-Cert released but real rule-making needed
Healthcare IT News: The FDA continues to move at a fast pace to develop and, soon, implement its pre-certification program for medical software development. Yesterday the agency released a second draft of its Pre-Cert framework, incorporating some of the comments it received about the April first draft and seeking additional comments on other parts of the framework.
The basic goal of the Pre-Cert program, which sets it apart from previous FDA regulatory ventures, is that it will focus not on particular products but on firms and developers.
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