The De Novo Petition – Is There Hope at FDA for Lower Risk, Innovative Devices?

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In late 2011, FDA issued a new draft guidance on the de novo process, and legislation is pending that would streamline the system.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.

Companion Diagnostics - What Pharma Needs to Know About IVDs

is being presented by David Kern, Senior Director, RAC MBA and airs on Wednesday, April 20th, 2011. For more details, or to register please visit our site at www.fxconferences.com

If you are contemplating a companion diagnostics program, or if you already have such a program in place, you need to live in both the drug and diagnostic worlds. One key component to securing FDA approval – and staying in compliance – is understanding how in vitro diagnostics are regulated. Is your test a 510(K) or a PMA? What is the difference between an LDT and an IVD? Does FDA care about ISO standards and certification? This audio conference presentation reviews the current regulatory landscape for IVD tests, as well as lab-developed tests and companion diagnostics, focusing on the things pharma companies need to know.

Indications: The Next Battleground in FDA Advertising Enforcement

Recent Supreme Court decisions have provided new protection to commercial speech, challenging the manner in which FDA regulates industry. In response, FDA takes great care to not mention advertising and has shifted its enforcement focus to indications.

The Food, Drug, and Cosmetic Act (FDCA) does not give FDA broad control over advertising, yet it does give FDA explicit control over the approval/clearance process and the resulting indications. FDA is tightening up on statements in ads by closely interpreting indications. This makes it even more critical to plan and write accurate PMA and 510(k) scopes to prevent FDA enforcement.

This audio conference discusses the best way to work within the new reality of FDA advertising enforcement.

Indications: The Next Battleground in FDA Advertising Enforcement was presented by Robert J. Klepinski, of Fredrikson & Byron and aired 2007-01-18. For more details or to purchase a download of this event, please visit our site www.fxconferences.com