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# No First Amendment Court Battle for This Device Company
- URL: https://www.fdaweb.com/no-first-amendment-court-battle-for-this-device-company/
- Published: 2016-01-13T12:00:00.000Z
- Updated: 2026-09-15T02:27:11.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5134429

Recent drug company court victories ([see earlier story](http://fdaweb.com/login.php?sa=v&aid=D5134219&searchWords=first%20amendment&cate=S&stid=%241%243R5.Ou5.%24b4UxIFmBGtUywduId0aNX0&ref=fdaweb.com)) against FDA involving First Amendment challenges over off-label promotion did not motivate medical device maker LED Medical to fight a 5/2014 Warning Letter citing certain marketing verbiage on the company’s Web site pertaining to its VELscope Vx system. The company says it completed the requested changes to the Web site in December 2015 and received notification shortly thereafter that the changes were acceptable.

“This confirmation brings to a conclusion the negotiations between LED Dental and the FDA regarding certain marketing verbiage on the LED Dental Web site pertaining to the VELscope Vx system,” the company says. “Although we felt justified in the language that we originally utilized, we also understand the agency’s position and, in the end analysis, do not feel that the FDA’s requested changes diminish in any way the compelling value proposition of the VELscope Vx communicated on our Web site.”

FDA’s [Warning Letter](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm397798.htm?ref=fdaweb.com) said the device was cleared with the following indications for use: VELscope Vx is intended to be used by a dentist or health-care provider as an adjunct to traditional oral examination by incandescent light to enhance the visualization of oral mucosal abnormalities that may not be apparent or visible to the naked eye, such as oral cancer and premalignant dysplasia. Also, it is intended to be used by a surgeon to help identify diseased tissue around a clinically-apparent lesion and thus aid in determining the appropriate margin for surgical excision. “However,” the letter told LED Medical, ”your firm’s promotion of the device provides evidence that your firm is marketing it for early detection of oral mucosal abnormalities, which would constitute a major change or modification to its intended use, for which your firm lacks clearance or approval,” the letter said.

The letter had objected to numerous product claims on the Web site, including the following:

- “Detecting oral abnormalities early leads to more treatment options, potentially less invasive or radical treatments and better patient outcomes”
- “Introducing the VELscope Vx Enhanced Oral Assessment System, which centers on a wireless, handheld scope that applies tissue fluorescence visualization to identify oral mucosal abnormalities early – often months or even years before they can be identified with the unassisted eye”
- “Cleared by FDA, Health Canada, and the World Health Organization, the winning VELscope Vx is the world’s most widely used adjunctive device for the discovery of Viral, fungal and bacterial infections; inflammation from a variety of causes (lichen planus and licheniod reactions, allergy to amalgam fillings, etc); Squamous papillomas; Salivary gland tumors; Cancer and pre-cancer; Other oral mucosal conditions.”
- “The VELscope Vx, the latest model release of VELscope technology, uses natural tissue fluorescence to discover abnormalities in the oral mucosa”
- “The VELscope Vx system enchances the way practitioners examine the oral mucosa and screen for tissue abnormalities, potentially leading to the earlier discovery of pre-cancer, cancer or other disease processes.”
- “Early detection is one of the best mechanisms for enabling treatment success, increasing survival rates and maintaining a high quality of life.”