Posts made in July, 2015

Key compliance dates in the UDI final rule. Compliance Date Requirement September 24, 2014 All Class III devicesThe labels and packages of class III medical devices and devices licensed under the Public Health Service Act (PHS Act) must bear a UDI. § 801.20.Dates on the labels of these devices must be formatted as required by § 801.18. Data for these devices must be submitted to the GUDID database. § 830.300. A 1-year extension of...

The purpose of the FDA Pre-Submission Program* (formerly Pre-IDE) and Meeting with FDA  is to provide a mechanism for applicants through which they can request feedback from the Food and Drug Administration (FDA) regarding potential or planned 1) Medical device Investigational Device Exemption (IDE) applications, 2)  Premarket Approval (PMA) applications, 3) Humanitarian Device Exemption (HDE) applications, 4) De novo Petitions...