Laura and Liz are both on track and asking the right questions. Here are a few additional points to consider:
Generally speaking, if product claims/advertising remain within the cosmetic boundaries of section 201(i) of the FD&C Act, then it can often be regulated as a cosmetic, not a device. In fact, I have a 'device-turned-cosmetic' client who was cited in an unexpected FDA medical device inspection for failing to meet medical device requirements after making therapeutic claims. The product consists of a combination of liquid solutions rubbed on the skin
and a machine used for application. Moreover, the machine component is actually a repurposed medical device whose inherent characteristics are often regulated as medical device features. But after negotiations with FDA and revision of the advertising literature, FDA accepted the re-categorization of the product (skin solutions
and the machine) as a cosmetic. So that kind of general precedent exists.
However, my prior experience analyzing the FDA regulatory and 510(k) requirements of blue-light-emitting devices leads me to believe that a blue-light-emitting instrument could be inherently disqualified from being regulated as a cosmetic, consequently requiring regulation as a medical device. My sense on this is based on blue light's inherent effect on the body, and/or its inherent risks, combined with the intent of section 201(h)(3) of the FD&C Act (aforementioned by Liz). Specifically, my understanding is that blue light often results in skin redness or scaliness likened to a sunburn, where the presence of prior skin damage can worsen these effects, sometimes even causing significant burning or discomfort in the treated area. Such inherent characteristics may cause FDA to inherently regulate blue-light-emitting instruments as medical devices. If not, it would need to be supported by a proper risk analysis systematically and methodically confirming that no such risks exist.
We've seen FDA take similar stances with non-medical products before. For example, theatrical/cosmetic contact lenses have no therapeutic effect, yet are nonetheless regulated by FDA as medical devices due to their inherent risk profile.
Perhaps other Forum members can help confirm the issue. But for conclusive direction and to know the ground rules before making too much of an investment, affected firm's should consider contacting the responsible FDA Branch Chief (Neil Ogden) in FDA's CDRH ODE Division of Surgical Devices, General Surgery Devices Branch One. Or submit a well-written 513(g) request.
By the way, to give some additional background, here is the usual FDA classification regulation and a couple product codes thereunder that are typically applied by FDA for blue-light devices:
- 21 CFR 878.4810, "Laser surgical instrument for use in general and plastic surgery and in dermatology":
- Product Code ONE (powered Light Based non-laser Surgical Instrument)
- Product Code ONF (powered light based non-laser surgical instrument with thermal effect)
Notice my emphasis added, where non-laser (e.g., LED) devices are lumped by FDA under the laser regulation even though these are not lasers.
Hope this helps,
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Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
Principal Consultant
ComplianceAcuity, Inc.
Golden CO
United States
www.complianceacuity.com© Copyright 2018 by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 10-Apr-2018 14:43
From: LAURA HOSHUE
Subject: Blue LED Light Device
Team,
We are in the process of creating a device that has blue light. Management wants to steer away from any medical claims whatsoever and would like to remain cosmetic in nature. Does a device containing blue light, even with no medical claims, still require FDA approval? Does the fact that it has blue light make it a medical device? I know that blue light is used in the treatment of acne, but if we were to not mention any medical benefit, would that keep us in the clear?
Please advise.
Thanks,
Laura
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Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
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