Microneedling Classification Order

Microneedling Classification Order

The FDA issued a Microneedling Classification Order that will fundamentally reshape how microneedling devices are sold and used. The classification order (link here) was issued in response to a De Novo application submitted by Bellus Medical. The Microneedling Classification Order follows a microneedling guidance issued on Sept. 14, 2018. The Draft Guidance document is available here. (Previous posts on microneedling can be found here and here.)

Classification Order is Mandatory Across Industry

Unlike the microneedling guidance, the Microneedling Classification Order is binding and mandatory. It doesn’t contain recommendations but a classification that applies to all similar devices.

What are similar devices? The classification order created a new medical device product code, QAI, and a general definition. Microneedling medical devices are now defined in the Code of Federal Regulations as:

Microneedling device for aesthetic use. A microneedling device for aesthetic use is a device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use. This classification does not include devices intended for transdermal delivery of topical products such as cosmetics, drugs, or biologics.

This broad definition will impact every microneedling device currently on the market. Prior to the Microneedling Classification Order, a company might attempt to avoid the medical device classification by claiming the product was Class I or more recently by claiming the technical features fit within the microneedling draft guidance. Those arguments will now likely fail, which would lead to enforcement action, including recalls or a stop on all sales.

Implications for Doctors and Estheticians

The classification order is also important to doctors and estheticians. Not only is there now only one microneedling device cleared by the FDA, but also a clear statement of risks. The FDA classified microneedling devices as Class II meaning specialized controls are necessary to provide a reasonable assurance of safety.

These risks are serious enough the device is classified as prescription (Rx) only. In some states, this may limit who can provide microneedling treatment.

The sale or use of an unapproved medical device now carries serious risk, such as product liability, that should be evaluated.

The Microneedling Classification Order marks the beginning of when microneedling is seen as a medical device and not something stuck in a grey area.

 

**Disclaimer: Marc C. Sanchez, Esq. is a FDA attorney in private practice and the above is not intended as legal advice. FDA Atty law firm is hosting this blog solely for educational purposes. Mr. Sanchez also worked with Bellus Medical on its De Novo submission.**

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Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

1 Comment

  1. […] K030028). It’s also important to remember how the FDA defined microneedling (previous post here). That definition […]

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