Home » FDA Recall, 510(k) Guidances Continue ‘Risk-Averse’ Trend
FDA Recall, 510(k) Guidances Continue ‘Risk-Averse’ Trend
The FDA’s devices center continues to avoid taking risks in guidance documents and other activities, and one industry insider blames a “perfect storm” of conditions: a generally inexperienced review staff, criticism of the 510(k) program and aggressive performance goals set during user fee negotiations that were not coupled with performance standards.
Devices & Diagnostics Letter
Devices & Diagnostics Letter
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