General Wellness Products How to Make the FDA’s New Rules Work for You

MessageThis Webinar is over
Date Feb 25, 2015
Time 11:00 AM EDT
Cost $287.00
Imagine. A class of products with no FDA inspections, approvals or chance of being pulled from the market by the agency.

The FDA has decided that it will NOT regulate a class of low-risk products it calls general wellness products.

This boon to the industry will allow your plans for some devices and apps to move forward much more quickly … without the burden of regulation.

There's just one snag. Exactly what is the FDA's definition of general wellness?

You'll learn the answer to this question (and others) at FDAnews' Feb. 25 webinar General Wellness Products: How to Make the FDA’s New Rules Work for You.

This new product category creates enormous opportunities for manufacturers. And the idea that you can tailor your products to be part of an unregulated classification is an exciting one. Nonetheless, there still are some rules you must follow.

In this session, regulatory expert Frederick Stearns will explain what the new general wellness rules mean and what you will need to do to make sure your devices and apps qualify for this new category.

Rest assured, though, you will come away from the webinar understanding how to get your devices and apps on the market without having to deal with FDA clearance or approval. Specifically, you'll learn:

• How to be sure your product's health claims are considered wellness claims, not treatment claims that will run afoul of the FDA’s rules.
• How to make your device satisfy FDA criteria for low-risk treatment
• 10 health claims you can make without triggering an FDA review
• 6 specific claims that the FDA guarantees will cause you problems
• The agency’s 5-step test to determine whether your device falls under the FDA’s general wellness exemptions

There's no time like NOW to learn all the ins-and-outs of the new FDA guidance about general wellness products. Sign Up TODAY for this timely webinar, General Wellness Products: How to Make the FDA’s New Rules Work for You.

Meet Your Presenter
Frederick Stearns is a partner at the law firm Keller and Heckman. His practice involves a wide range of issues affecting manufacturing of prescription and over-the-counter drugs, medical devices, dietary supplements, and cosmetics.
Mr. Stearns helps product manufacturers evaluate the need for marketing approval from FDA, to pursue appropriate clearance when necessary, and address regulatory compliance issues with marketed products (including OTC drug monographs, product labeling and promotion, and current good manufacturing practices).
He also works with clients to respond to FDA enforcement activities, navigate the interrelationship of the patent laws and the FDA drug approval process, communicate with Agency officials, and develop innovative strategies to deal with evolving FDA regulatory requirements. In addition, Mr. Stearns has worked with numerous companies to conduct FDA due diligence reviews, both for internal control purposes and as part of product line or corporate acquisitions.
Mr. Stearns is a frequent speaker at conferences on the legal issues involving the regulation of drugs, medical devices, and dietary supplements.

Who Will Benefit
• Regulatory affairs professionals
• App Developers
• Regulatory attorneys

Conference Details:
General Wellness Products
How to Make the FDA’s New Rules Work for You
**FDAnews Webinar**
Feb. 25, 2015 — 11:00 a.m. – 12:30 p.m. EST

Easy Ways to Register:
By phone: 888-838-5578 or 703-538-7600



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