FDAnews -- FDA Announces Critical Guidance for Apps Developers

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The FDA has decided that it will not regulate a class of low-risk products it calls general wellness products. In the General Wellness Products webinar, regulatory expert Frederick Stearns will explain what the new general wellness rules mean and what devicemakers will need to do to make sure their devices and apps qualify for this new category.

General Wellness Products:
How to Make the FDA’s New Policy Work for You
**FDAnews Webinar**
Feb. 25, 2015 — 11:00 a.m. – 12:30 p.m. EST
http://www.fdanews.com/GeneralWellnessProductsRules

Imagine if a device fell into a class where devicemakers 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?

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

In this session, regulatory expert Frederick Stearns will explain what the new general wellness policy means and what devicemakers will need to do to make sure their devices and apps qualify for this new category.

Specifically, attendees will learn:

  • How to make sure devicemakers make suitable wellness claims, not inappropriate treatment claims that will run afoul of FDA’s policy.
  • How to be sure a 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.

Meet the Presenter:
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).

Who Will Benefit:

  • Regulatory affairs professionals
  • App Developers
  • Regulatory attorneys

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

Tuition:
$287 per site

Easy Ways to Register:
Online: http://www.fdanews.com/GeneralWellnessProductsRules
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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