Testing The Limits: Software De Novo, 510(k) Volunteers Wanted By US FDA
Executive Summary
As the US Food and Drug Administration is developing a new pathway for certain medical software called the precertification program, the agency is asking de novo and 510(k) sponsors to volunteer for a test plan to help the agency in its efforts. At least one expert on the subject is skeptical and says the plan adds burdens without real benefits for sponsors.
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