On December 31, 2012, FDA issued two final guidances that replace prior guidances related to the review of premarket submissions: “Refuse to Accept Policies for 510(k)s” and “Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)” (hereinafter referred to as the 510(k) RTA Guidance and PMA Acceptance and Filing Guidance, respectively). Both guidances went into effect on December 31, 2012 and were issued to help FDA meet its performance goals under the Medical Device User Fee Amendments of 2012 (MDUFA III). We expect FDA to apply the 510(k) RTA and PMA Acceptance and Filing criteria stringently, at least in the near future, resulting in a greater number of submissions not being accepted and/or filed. Therefore, we recommend companies pay close attention to the RTA and Acceptance and Filing criteria and prepare their submissions accordingly.

This client alert highlights key aspects of these guidance documents. Copies of the complete guidance documents are available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Guidanc eDocuments/ucm162707.htm.