The US Food and Drug Administration’s Center for Devices and Radiological Health has released two new guidance documents which can be read here, relating to how the agency plans to calculate review time and goals for medical device submissions under the Medical Device User Fee Act, part of the FDA Safety and Innovation Act. Two of the most common forms of medical device submissions: 510(k) applications and premarket approval applications (PMAs) are referenced in the guidance documents. The FDA has put an aggressive approach to clear 510(k) devices in 135 calendar days on average in 2013, decreasing to 124 by 2017. For PMAs, FDA has five options available for it to put halt to the review clock. For further insight on 510(k) submissions, click here. To learn more about PMAs on the guidance documents, click here.
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