Most medical device companies take their products to FDA prior to marketing. But is there a way to legally market a medical device without taking it to FDA first?
Maybe! The “general wellness exemption” provides a way to legally market certain medical devices without FDA clearance or approval.
Is this a new idea? Absolutely not! Companies having been doing this for decades; however, some companies have gotten in trouble for doing so improperly.
To help, FDA issued the General Wellness: Policy for Low Risk Devices guidance here. Despite this guidance, many companies still struggle with understanding which devices qualify under the wellness exemption and what documentation is necessary to support such a claim.
In addition, many companies don’t realize that the same device may be marketed as both a wellness device and as a 510k, de novo or even PMA at the same time. In fact, the wellness exemption offers an opportunity for label expansions to FDA regulated devices in the future.
When used effectively, the general wellness exemption offers significant advantages in to market sooner. But if not used properly, the wellness exemption can significantly increase the regulatory risk of punitive action.
In this presentation, participants will learn best practices to avoid timely and costly mistakes and creative ways to use the general wellness exemption to their advantage!
Medical Device Industry Executives
Regulatory Affairs Professionals and Management
Quality Professionals and Management
Clinical Affairs Professionals and Management
R&D Engineers and Management
Michael Drues, Ph.D., is President of Vascular Sciences, a consulting and training company offering a broad range of services to medical device, pharmaceutical & biotechnology companies including creative regulatory strategy & competitive regulatory intelligence, regulatory submission design, FDA presentation preparation & defense.
Dr. Drues received his B.S., M.S., and Ph.D. degrees in Biomedical Engineering from Iowa State University in Ames, Iowa. He has worked for and consulted with leading medical device, pharmaceutical and biotechnology companies ranging in size from start-ups to Fortune 100 companies. He also works on a regular basis for the U.S. Food and Drug Administration (FDA), Health Canada, the US and European Patent Offices, the Centers for Medicare and Medicaid Services (CMS) and other regulatory and governmental agencies around the world.
Dr. Drues is an internationally recognized expert and featured keynote speaker on cutting-edge medical technologies and regulatory affairs. He conducts seminars and short-courses for medical device, pharmaceutical and biotechnology companies, the U.S. Food and Drug Administration (FDA), Health Canada, the US and European Patent Offices, the US Centers for Medicare and Medicare Services (CMS) and other regulatory and governmental agencies around the world.
Finally, as an Adjunct Professor of Medicine, Biomedical Engineering & Biotechnology, Dr. Drues teaches graduate courses in Regulatory Affairs & Clinical Trials, Clinical Trial Design, Medical Device Regulatory Affairs & Product Development, Combination Products, Pathophysiology, Medical Technology & Biotechnology at several universities & medical schools onground & on-line.
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Valscular Sciences is a consulting and training company offering a broad range of services to medical device, pharmaceutical & biotechnology companies including creative regulatory strategy & competitive regulatory intelligence, regulatory submission design, FDA presentation preparation & defense. For additional information, contact Dr. Drues at (508) 887-9486, e-mail mdrues @ vascularsci.com or via LinkedIn.