is being presented by Michael A. Swit, Principal, with Law Offices of Michael A. Swit and airs on Wednesday, February 15th, 2012. For more details, or to register please visit our site at www.fxconferences.com
The 'de novo' 510(k) petition process presents a unique opportunity for medical device companies to bring products to the market without having to go through the more lengthy and expensive route of a Premarket Approval Application (PMA).
In 1997, recognizing that many innovative devices put into Class III presented lower risks, Congress revised the medical device laws to create the de novo petition. It allows a company to petition FDA to move a device that has been automatically classified into Class III to Class II or even Class I. While designed to relieve the regulatory burden on industry, the de novo petition process has presented many challenges. Less than 70 devices have successfully undergone the de novo process. And, the process is not easy. Before pursuing a petition, a firm must first file a 510(k) and have FDA deny the submission as not substantially equivalent.
In late 2011, FDA issued a new draft guidance on the de novo process, and legislation is pending that would streamline the system. This audio conference explores how to take advantage of the de novo process, challenges linked to the process and how to best position your petition for success.
