Tuesday, 23 June 2020 10:08

LED - Does FDA Clearance Matter?

Written by   Pam Cushing

As a skin care professional, does a device’s FDA credentials really make a difference?  Isn’t the FDA something doctors deal with?  For treating the superficial layers of the skin, do devices with FDA credentials work any better than those that don’t? Don’t FDA credentials just make devices more expensive?  All great questions for today’s skin care professional.

 

The Food and Drug Administration (FDA) is an agency within the United States Department of Health and Human Services (HHS). It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency – Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations. The FDA is responsible for protecting the public health by assuring safety and effectiveness.

 

The FDA regulates any medical claims made by device manufacturers.  Accordingly, before any medical claims can be legally made by a device manufacturer, those claims must be reviewed by the FDA for both efficacy and safety. The FDA does not test devices themselves, however, they thoroughly analyze the data submitted by manufacturers or sponsors to ensure that the claims being made about the device are substantiated and that users of the products can expect effective and safe performance – relative to the claims.

 

 

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Pam Cushing

 

 

 

Pam Cushing is a registered nurse with over 35 years of experience in emergency medicine. She has worked in the field of aesthetics for over 15 years, full-time for the last five years. Cushing holds a degree at the master’s level, with commendation, as well as a post-graduate diploma in aesthetic medicine, with merit. She is an independent nurse prescriber in the United Kingdom. Cushing is a consultant educator for a couple of companies educating in injectables, skin resurfacing and chemical peel, microneedling, and LED. She thrives on being able to educate, motivate, and encourage others to grow and develop professionally. She is passionate about skin and the benefits of aesthetics in improving the confidence and quality of lives. Cushing believes our key role is to educate the consumer on appropriate treatment modalities with the focus on maintaining skin health.

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