Why should you attend :
As the vast majority of moderate risk medical devices are cleared for marketing through the 510(k) process, these changes can have a substantial impact on the way industry does business. This presentation will discuss the background behind FDA’s decision to modify the 510(k) process, outline the progress it has made in 2011and 2012 to implement these changes, and take a look at what changes are yet to come in 2012 and beyond.
Q/A Session with the Expert to ask your question
PDF print only copy of PowerPoint slides
90 Minutes Live Presentation
Description of the topic :
In 2010, FDA issued a report on the changes it plans to make to the 510(k) process to address regulatory, industry, and consumer concerns and 2011 and 2012 have been marked by the agency’s progress in implementation of these changes. In the past year, the agency published a draft guidance document that revises and clarifies the agency’s longstanding policies regarding when a new 510(k) submission will be required for changes being made to an existing device and another draft guidance document which creates a second alternate de novo pathway for devices found to be not substantially equivalent (NSE) at the end of the 510(k) process.
FDA has also issued a draft guidance document which would change and clarify other aspects of the agency’s 510(k) program in an attempt to foster more consistency across 510(k) reviews, coupled with training and certification for FDA device reviewers. Other 510(k)-related guidance documents have issued as well.
Who will benefit:
Representatives of manufacturers and marketers of 510(k) medical devices, including in-house counsel, outside FDA counsel, regulatory affairs personnel, and regulatory consultants.
Mr. Evan P. Phelps is a principal at OFW Law. Mr. Phelps advises companies on compliance with Food and Drug Administration (FDA) law and regulations, with focus on matters related to medical devices and biologics as well as those affecting Clinical Investigators.
Casper E. Uldriks , counsel at OFW Law, was born in Battle Creek, Michigan . He began his 30+ year career as an investigator at FDA in 1978. He graduated with his B.A. in 1973 from Albion College, his Master of Divinity from Boston University in 1976, and his J.D. from Suffolk University Law School in 1986. He was admitted to the Massachusetts Bar in 1986 and the DC Bar in 2011. For years he has trained FDA staff on medical law and has been a featured speaker at many professional conferences involving FDA's medical device program.
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