Ironically, the U.S. Food and Drug Administration (FDA) is sometimes wary of issuing guidances out of concern it will appear to be imposing new rules that will stifle innovation, according to Ken Skodacek, a policy analyst for the Clinical Trials Program at the Center for Devices and Radiological Health (CDRH). Of course, the tension here is that many in industry hold off implementing a new program out of fear the FDA won’t like its approach, e.g., mobile health and 21 CFR Part 11.

The agency is trying, with renewed vigor, to find that balance between giving industry direction without making it feel handcuffed.

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