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 The Draft Guidance document is available here.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by claiming the product was Class I or more recently by claiming the technical features fit within the microneedling draft guidance.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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[…] K030028). It’s also important to remember how the FDA defined microneedling (previous post here). That definition […]