Dermal Tone Inc.

We are writing to you because we have obtained information that has revealed a serious regulatory problem involving a product known as “Dermal Tone,” which is marketed by your firm. The Dermal Tone is promoted and sold on the Internet at www.dermaltone.corn. See enclosed website material dated 6/29/00. This website material states that “The Dermal Tone is an electronic device which sends out tiny amounts of electricity to designated areas of your face which causes muscles to flex and relax, exercising them for you.” The product is being sold Over the Counter (OTC) through mail order via the Internet and through an Infomercial.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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