Preparing and Submit a Compliant 510(k) Submission
OVERVIEW Since September 2009, the Centre for Devices and Radiological Health has been reviewing the operation of the 510(k) program and the way CDRH uses science in the decision making process. In August 2010, the 510(k) Working Group and the Task Force on the Utilization of Science in Regulatory Decision Making each released a preliminary report with a series of recommendations. Overall, industry has provided mostly a positive response but with exceptions. The proposals are more benign than many had feared. No radical change to the current process appears likely. Bottom line, FDA issued two comprehensive evaluations containing recommendations that address three key objectives of the agency’s public health mission as it relates to medical devices – foster device innovation, create a more predictable regulatory environment, and enhance device safety. 510 K Submission Process WHY SHOULD YOU ATTEND This webinar provides an overview of the premarket notification process an...