General Wellness Products - Webinar CD/Transcript

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

Imagine if your device fell into a class where you no longer had to worry that it could suddenly be declared an unapproved medical device by the FDA and forced to seek clearance or, worse, be pulled from the market.

Well, that’s exactly the case for a new class of low-risk general wellness products.

In new guidance, the agency says it will exercise its enforcement discretion and not regulate certain apps and other products that help manage weight loss, fitness, stress or other aspects of good health as medical devices.

In another unexpected — but welcome — move, the FDA will also defer regulation of products making certain disease-specific claims, as long as certain conditions are satisfied. 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) with the webinar CD and transcript General Wellness Products: How to Make the FDA’s New Policy 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 policy means and what you will need to do to make sure your devices and apps qualify for this new category.

The FDA has specific expectations about the types of claims companies can make for these products and the conditions they can address. Step outside those boundaries and you could be back squarely in the Agency’s regulatory crosshairs.

Rest assured, though, you will come away from the webinar understanding how the new general wellness policy applies to you and how to position products as general wellness articles that do not require FDA oversight.

Specifically, you'll learn:

  • How to make sure you make suitable wellness claims, not inappropriate treatment claims that will run afoul of FDA’s policy.
  • How to be sure your device satisfies FDA criteria for a “low-risk” product
  • Review specific examples of claims that do, and do not, comply with the policy
  • Understand the new flexibility available for certain “disease” related claims
  • Explore factors to consider to expand application of the policy beyond FDA’s limited examples

There's no time like NOW to learn all the ins-and-outs of the new FDA guidance about general wellness products.

  • Regulatory affairs professionals
  • App Developers
  • Regulatory attorneys

Frederick Stearns, partner at the law firm Keller and Heckman LLP in Washington, DC. 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.