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FDA seeks participants for pilot program on high-risk device PMAs

The FDA is looking for participation from nine companies in its pilot Premarket Approval Application Critical to Quality program, which is intended for streamlining the approval process for high-risk medical devices. The program, which will run from Sept. 29 until either Dec. 31, 2018, or until nine premarket approval applications have been signed up, also aims to ensure the inclusion of rigorous controls for critical device features and characteristics in companies' quality systems.

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