July 2012 • This is a “proposed rule” (no actual regulations have been amended/promulgated yet). The proposed rule is due for publishing via FR next week. • Stakeholders will have 120 days to lodge comments/concerns with FDA before FDA initiates the “final rule” stage. • All devices [201(h) of the Act] will require UDI except: […]
<h1 class="entry-title">Category: FDA</h1>
FDA to implement or reach a major milestone this year (2011) for forty-two of its prior fifty-five 510(k)-process recommendations
January 2011 In August 2010, FDA released for public comment a two-volume set of documents entitled “[CDRH] Preliminary Internal Evaluations,” which is comprised of the preliminary reports of two internal committees: The 510(k) Working Group and the Task Force on the Utilization of Science in Regulatory Decision Making. Volume I is entitled “510(k) Working Group […]
Industry has until October 4th to comment on FDA’s 510(k) recommendations released July 30th
August 2010 The Food and Drug Administration’s (FDA’s) premarket notification (510(k)) process for the review of medical devices was established in 1976 and provides a more abbreviated mechanism of medical device premarket clearance than FDA’s Premarket Approval (PMA) process. As indicated by FDA, the 510(k) program, as it currently exists, aims to support FDA’s public […]
FDA releases its final guidance document on statistical aspects of the design and analysis of clinical trials for medical devices that use Bayesian statistics
February 2010 On February 5, FDA released its final guidance document on statistical aspects of the design and analysis of clinical trials for medical devices that use Bayesian statistical methods. Bayesian statistics is an approach for learning from evidence as it accumulates. In clinical trials, traditional (frequentist) statistical methods may use information from previous studies […]