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Regulating Medical Devices for Beauty: Part I—Determining Class

Contact Author Pawel Leja, Daniel Noble and Robert Ross-Fichtner May 2015 issue of Skin Inc. magazine
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Regulating medical devices

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Editor’s note: This article originally appeared in the March 2015 issue of Cosmetics & Toiletries magazine (www.cosmeticsandtoiletries.com) as an online exclusive and is being republished with permission. All rights reserved.

An increasing number of developments in the beauty industry involve devices, which are often used in combination with cosmetic products.

Depending on their purpose, some beauty devices are actually regulated as medical devices.

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In the United States, the U.S. Food and Drug Administration (FDA) defines a medical device as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory that is:” recognized in the National Formulary or the United States Pharmacopoeia; intended for use in the cure, mitigation, treatment or prevention of disease; or intended to affect the structure or any function of the body without a chemical action and without being metabolized.1

It is this latter definition that is relevant to the cosmetics industry.

Determining Class and Approval Process

The regulatory structure for medical devices is based on an understanding that not all products are created equally.

Globally, medical devices are broken up into three or four different classifications, depending on geographical location, and these classifications are differentiated by the risk of the product.

For example, a simple bandage is considered a Class I medical device, and an implantable cardiac pacemaker can be Class III or IV, depending on jurisdiction.2 With each increasing class, the regulatory requirements are more stringent.2 This is a thoughtful model that could also be applied to cosmetics or drugs.

The FDA recognizes three classes of medical devices.3 Within this system, there are two regulatory pathways that allow for the marketing of medical devices. The first pathway is the 510(k) process. This is the most common gateway, and it works by: comparing a new device to one already cleared by the FDA, and deeming the two devices are “substantially equivalent.”4

In doing so, the medical device is “cleared” by the FDA and can be brought to market.5 The other pathway is the premarket approval process (PMA). This option tougher and is similar in nature to a new drug approval. Clinical data also is often needed to support the claims for a medical device.

The premarket notification 510(k) application is not needed for most Class l devices, but it is for some Class ll devices.6 If a notification application is needed, the product cannot be commercially distributed until the device is found to be “substantially equivalent” to a previous device.5

This notification process is generally required for Class ll medical devices and some Class lll instruments.7 Since Class lll devices are primarily used to assist or sustain life, a PMA is often required for Class lll devices due to the higher risk.8

Device technology can provide the consumer with superior results during their beauty routines; however, they involve entirely new regulatory and quality paradigms that may be foreign to practitioners in the skin care industry.

Part II and III of this three-part column series will appear in the June and July issues of Skin Inc., and will continue to discuss the various categories of esthetic medical device products.

REFERENCES

  1. www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051512.htm
  2. www.cadth.ca/en/products/environmental-scanning/health-technology-update/health-technology-update-issue5/medical-device
  3. www.marsdd.com/mars-library/medical-device-regulations-classification-and-submissions/
  4. www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm070201.htm
  5. www.hc-sc.gc.ca/dhp-mps/md-im/activit/fs-fi/meddevfs_matmedfd-eng.php
  6. www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/directives/gui-0016-eng.php
  7. www.mddionline.com/article/engineer-takes-medical-device-regulatory-process-part-ii
  8. www.devicewatch.org/reg/510k.shtml

(All websites accessed Mar 20, 2015)

Rob Ross-Fichtner, president and CEO of Focal Point Research, has more than 30 years of experience in the formulation, manufacturing and regulation of cosmetics and OTC drugs. Pawel Leja and Daniel Noble both have participated in Focal Point’s student intern program.

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