To embed, copy and paste the code into your website or blog: Considering the tight timeline for preparing responses to FDA compliance actions coupled with the agency’s expectation for timely implementation of corrective and preventive actions, the benefit of obtaining feedback through the Q-submission program (also referred to as a “pre-submission”) may be limited. To start off the new calendar year, FDA issued a revised version of its guidance document on the Q-submission program on January 6, 2021, “ Obtaining feedback on submissions that may qualify for FDA’s recently announced Safer Technologies Program (STeP), also launched on January 6, 2021 (see Guidance Document). The STeP Program provides an expedited review and authorization process for certain device and device-led combination products that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics that target an underlying disease or condition associated with morbidities and mortalities less serious than those eligible for the Breakthrough Devices Program.