Collecting Post-Market Device Data Without Running Afoul of FDA

is being presented by Robert J. Klepinski, Regulatory Attorney, with Fredrikson & Byron and airs on Thursday, January 19th, 2012. For more details, or to register please visit our site at www.fxconferences.com

Most medical device companies today wish to gather data on product use and performance without being entangled in expensive IDE negotiations. However, recent FDA enforcement actions have brought new scrutiny to post-market studies. FDA has combined accusations of off-label promotion with enforcement against studies collecting data on usage deemed to be outside cleared labeling. So what are device manufacturers to do? Is there still a path available for collecting this important information? This audio conference explores the regulations involved, recent enforcement actions by FDA, the difficulties in ascertaining the scope of indications today, and ways to gather information within the current enforcement environment.

FDA on the Edge: What's Next for 510(k)?

is being presented by Robert J. Klepinski, Regulatory Attorney, with Fredrikson & Byron and airs on Thursday, June 2nd, 2011. For more details, or to register please visit our site at www.fxconferences.com

Various tracks are coming together in 2011 which will affect the manner in which 510(k)s and other submissions will be reviewed by FDA. The Institute of Medicine report has been peer-reviewed and is expected to be released shortly. However, the FDA list of intended changes contains several items that are about to change, regardless of IOM recommendation.

For medical device manufacturers, it is a time of expectation and, perhaps, a little trepidation. This audio conference takes a look at what is likely to change, and discusses how best to prepare for this new reality.

Intended Use & Indications for Use – Does Anyone Know What They Mean? Does FDA?

is being presented by Robert J. Klepinski, Regulatory Attorney, Of Counsel, with Fredrikson & Byron and airs on Thursday, January 13th, 2011. For more details or to register, please visit our site at www.fxconferences.com

Intended use. Indications for use. For years FDA has developed working definitions of these two terms, which vary from the definitions included in the regulations. Now FDA is questioning whether new definitions are needed. Previous industry use of the terms was based upon FDA's informal guidance, but if FDA doesn't know what they mean, does anyone?

In this audio conference, regulatory attorney Bob Klepinski discusses both the practical and the theoretical issues surrounding these two important terms and their use. The presentation looks at the statutory and regulatory definitions, and FDA's attempts to define them in guidance for industry. It also looks at what the future might hold, and how companies should proceed in the interim.

The New HIPAA and its Impact on Drug and Device Manufacturers

is being presented by Robert J. Klepinski, Regulatory Attorney, Of Counsel, with Fredrikson & Byron and airs on Thursday, July 1st, 2010. For more details or to register for this event, please visit our website at www.fxconferences.com

Manufacturers of medical devices and drugs had enough exemptions in the HIPAA privacy regulation that they could obtain most needed information in spite of the stringent controls on privacy rights. Occasionally such manufacturers needed to work under a Business Associate Agreement (BAA). However, the new statutory changes, including the privacy provisions of the HITECH Act, greatly increase the risk to manufacturers who work under BAAs. They are now directly liable under the HIPAA security regulations.

In this audio conference, FDA compliance attorney Bob Klepinski discusses the implications of this latest round of changes, how drug and device companies are expected to conduct themselves within this new HIPAA world, and the perils of failing to do so.

Device Design in the Current Regulatory Climate

The current regulatory environment is dominated by post-market issues. Recent high-profile drug recalls have caused physician groups, Congress, the press and FDA to take new interest in post-market issues. To survive and prosper in this environment, medical device designers must recognize and accept several key truths.

Unlike drug molecular design, device design is an evolving process, not a one-time event. Also, a medical device is not just hardware, as the product labeling determines its use and its regulatory status. The associated service and customer care can make the difference between success and failure. Therefore, each post-market event causes you to look back into your design process; how far back and in what detail to do so are the key process issues.

This presentation discusses the increase in post-market scrutiny, how it came about, and how device designers can best deal with it.

Device Design in the Current Regulatory Climate was presented by Robert J. Klepinski, with Fredrikson & Byron and is previously recorded. For more details, or to download this event please visit our site at www.fxconferences.com

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, Fredrikson & Byron and aired on 2007-01-18. For more details, or to register please visit our site at www.fxconferences.com

Device Advertising and the First Amendment: Your Rights

Within recent years the effect of the First Amendment on FDA-controlled speech has drastically changed. Courts have stated standards for what FDA can do in controlling speech in advertisements. The difficult question is predicting the practical impact of these court decisions. FDA still has enormous authority to control speech and labeling. In this presentation we discuss the balance between FDA control of indications versus court restrictions on FDA control of speech.

Device Advertising and the First Amendment: Your Rights was presented by Robert J. Klepinski, with Fredrikson & Byron, and aired on 2007-08-23. For more details or to download this audio conference, please visit our site at www.fxconferences.com

Good Reprint Practices: What the FDA Says Now

After years of arguing about the legality of distributing medical journal articles concerning unapproved uses for approved drugs and devices, the FDA has finally released a draft guidance recognizing such distribution as a normal activity. The guidance on Good Reprint Practices outlines the type of articles suitable for dissemination to healthcare professionals, the types of articles which should not be disseminated, and acceptable methods of distribution. However, in some ways this new guidance may be even more rigorous than past programs. It could even be argued that some of the provisions are unconstitutional.

In this audio conference, our speaker discusses the scope of the draft guidance on Good Reprint Practices and provide expert advice on implementing a program to ensure compliance for drug and device companies.

Good Reprint Practices: What the FDA Says Now was presented by Robert J. Klepinski, with Fredrikson & Byron and aired on 2008-09-04, and is available at www.fxconferences.com