We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Device Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » FTC Bars App’s Melanoma Detection Claims; Fine Assessed

FTC Bars App’s Melanoma Detection Claims; Fine Assessed

April 17, 2015

Health Discovery Corp. may not make any misleading claims about an app purported to diagnose skin cancer, the U.S. Federal Trade Commission says in a final consent order issued April 13.

The consent order follows a February complaint and subsequent comment period. In the complaint, the FTC said there was no scientific data supporting the company’s claim that its MelApp product can evaluate moles for melanoma symptoms (IDDM, Feb. 27).

To use the app, customers would photograph the mole on a mobile phone and input other information about it, and the app would categorize the mole as low, medium or high risk for skin cancer. Health Discovery claimed the app’s analysis was accurate and scientifically proven. The FTC, which regulates advertising, says it was not.

The consent order bars the company from claiming its device detects or diagnoses melanoma or its risk factors, unless the statement is supported by scientific evidence. While inspired by MelApp, the wording of the consent order would apply to any device manufactured by Health Discovery. Health Discovery will also pay $17,963 in penalties for violating the FTC Act.

In addition, Health Discovery must maintain all materials related to the consent order for five years and provide them to the FTC upon request. This may include advertising, scientific tests or demonstrations and acknowledgements of the receipt of the order. Health Discovery must report to the commission on its compliance within 60 days.

The commission voted 4-1 to approve the final consent order, with Commissioner Maureen Ohlhausen voting no. Ohlhausen says the regulatory crackdown could have a chilling effect on other medical app makers.

Regulation of mobile apps by the U.S. FDA is still developing, and spokesman Christopher Kelly declined to comment on Health Discovery specifically. However, he notes that unless otherwise ageed to in specific cases the FTC is in charge of regulation of the truth or falsity of advertising, while the FDA has primary jurisdiction over labeling.

View the final order at www.fdanews.com/04-20-15-melapp.pdf. — Elizabeth Orr

Regulatory Affairs

Upcoming Events

  • 10Mar

    FDA Drug GMP Facility Inspections During the Pandemic

  • 16Mar

    Pharmaceutical Naming Regulation: Understanding the Latest Developments

  • 18Mar

    Pharmaceutical Postmarket Surveillance: Latest Developments in the Era of COVID-19

  • 23Mar

    Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges

  • 30Mar

    Data Integrity for GMP/Postmarket Professionals: Core Requirements, Expectations and Challenges

  • 06Apr

    Medical Device Cybersecurity: Understand the Latest Developments

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • WhiteHouse.gif

    President Biden Issues Executive Order on U.S. Supply Chain

  • roche.gif

    Priority Healthcare Settles Diabetes Test Lawsuit with Roche for $43 Million

  • Effective text

    Pfizer/BioNTech Vaccine Equally Effective for All Age Groups, Israeli Study Says

  • Siemens Healthineers logo

    Siemens Healthineers’ COVID-19 Antigen Lab Test Receives CE Mark

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell My Personal Information
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Fax 703.538.7676 – Toll free 888.838.5578

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing