Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Improving radiation therapy dosing: FDA is holding a public meeting June 9 and 10 in Gaithersburg, Md., to discuss steps that makers of radiotherapy equipment - including linear accelerators, radiation therapy treatment planning systems and radiation therapy simulators - can take to reduce under- and overdosing and misaligned radiation exposures. FDA says it is rethinking pre-market approval requirements for such devices (1"The Gray Sheet" April 12, 2010). The first day of the workshop will focus on equipment features that should be incorporated into devices and software, and day two will focus on improving user training and quality assurance at medical facilities. FDA is accepting comments by May 15 in response to questions on device safeguards, facility reporting, training and quality assurance posted in a May 7 Federal Register 2notice. A related FDA initiative is addressing radiation overexposure in medical imaging procedures (3"The Gray Sheet" Feb. 15, 2010)
You may also be interested in...
Steris Agrees To Consent Order With FDA To Resolve Sterilizer Problems
Steris is offering credits and rebates to users of its troubled System 1 liquid chemical sterilization system under a transition plan called for in an April 19 consent decree with FDA
Regulatory News In Brief
Device reviewers miss some performance goals: FDA did not meet its fiscal 2008 goals for issuing decisions on certain device pre-market submissions, according to materials from FDA's latest quarterly update to industry. Federal law requires FDA to endeavor to reach a decision on 60% of pre-market approval submissions and panel-track PMA supplements within 180 days, and on 90% of PMAs and panel-track supplements within 295 days. In FY 2008, CDRH made decisions on 23 of 33 PMAs and panel-track supplement submissions. Some decisions are still pending, but in the best-case scenario, the center will miss its 295-day performance goal, and may miss its 180-day goal, as well. CDRH also missed its performance goals for expedited PMAs and expedited panel-track supplements (50% of decisions within 180 days and 90% of decisions within 280 days). The center similarly missed its performance goals for PMA modules, but will meet its performance goal for 180-day supplements and real-time supplements. CDRH also met its goal for 510(k) decisions, reaching decisions on more than 90% of submissions within 90 days and more than 98% of submissions within 150 days. CDRH received 3,848 510(k)s in FY 2008 and 4,103 510(k)s in FY 2009. And signals indicate that reviews may be speeding up. Average time to a final decision on PMAs and panel-track supplements was 215 days in FY 2008 and 172 days in FY 2009. 510(k) decisions took about 112 days on average in FY 2008 and 88 days in FY 2009, FDA says
FDA To Rethink Pre-Market Approval Process For Radiotherapy Devices
FDA hopes to reduce dosage errors and misaligned exposures during therapeutic radiation by rethinking pre-market approval strategies for certain radiation therapy devices