This week’s announced tentative agreement on a new “Medical Device User Fee Act” by FDA, AdvaMed, and other trade associations, including MDMA and MITA, deserves praise and requires scrutiny.

Praise because its provisions take monumental steps forward to establish important performance goals designed to improve FDA’s device review process. Scrutiny because in order for the performance goals to be met, accountability measures must be adhered to and proposed funding increases must happen.

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