The Microneedling Classification Update
The FDA formally issued a Microneedling Classification Order on Friday (link here). Unlike before, the Final Order is now codified in the Code of Federal Regulations (CFR). The effective date was Friday and will be codified as 21 CFR 878.4430, which marks the typical 90-days for the FDA to publish a classification order. If you thought the FDA might change its mind, insert exemptions or add more time, you’d be wrong.
A legally binding definition of microneedling is now in effect. That definition is, “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.”
It doesn’t matter if a derma roller or microneeding pen is used for acne, wrinkles, or simply for collagen induction. It also doesn’t matter if a device is used on the face, arms, or other areas of the body. If a device uses “…one or more needles to mechanically puncture and injure skin tissue for aesthetic use…” then this device type will apply and require pre-market approval.
There is no longer any question that microneedling in virtually every form is a medical device. The microneedling Guidance (available here) makes an extremely narrow exception for devices that exfoliate only dead skin tissue.
It’s also important to recognize the microneedling regulation now codifies the FDA’s position that a derma roller or microneeding pen used to deliver cosmetics or drugs deeper into the skin are combination drug-device products. Any brand making this type of claim is exposed to FDA Enforcement Action.
Enforcement Forecast
Unlike the microneedling guidance, the Microneedling Classification Order is binding and mandatory. The CFR is a significant source of regulatory law and extremely difficult to revoke. The CFR also has the benefit of being completely objective and clear.
The broad definition of this device type will likely result in the following enforcement actions:
- Imported derma rollers and microneedling pens will be flagged as unapproved medical devices, refused entry, and listed on Import Alert 89-08 until a 510(k) is filed;
- Facility inspections and website searches will lead to investigations and warning letters;
- The FDA may issue en masse warning letters to the largest companies to signal a shift in enforcement policy; and
- State departments of health may inspect facilities and issue embargos on unapproved device.
This range of actvities will likely begin before the end of summer.
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 fail to stop or mitigate any enforcement action.
Doctors and Estheticians Adopting Risks
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.
FDA has identified several risks to health associated specifically with this type of device and the measures required to mitigate these risks are listed in table 1 below.
These risks are serious enough the device is classified as prescription (Rx) only.
By using an unapproved medical device doctors and estheticians are adopting the risks of the brand they use and may be exposed to greater liability. This liability likely stems from exposing patients and clients to avoidable risks. A plaintiff will no doubt argue a responsible doctor or esthetician should have been aware of the FDA regulation and the articulation of risks it contained. For example, by reading a blog post like this one.
In many medical device liability cases, a doctor is shielded from liability when properly using a cleared and compliant device since the FDA review and clearance would ensure all likely hazards are controlled. That defense is totally washed away when using an unapproved medical device.
The implications are now crystal clear – microneedling devices pose a risk to patients which must be controlled by a device that the FDA has cleared through a 510(k) or De Novo review. Use outside of this is done at the doctors or estheticians own risk.
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| Identified risks | Mitigation measures |
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FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final Start Printed Page 26577order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act.
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**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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[…] enough simply to register and list as a Class I 510(k) exempt device (previous post with details here). The Final Classification Order is now codified in the Code of Federal Regulations (CFR) and can […]
So can tattoo artist legally microneedle or no, I’m so confused. I wanted to get certified in permanent make up and microneedling bb glow and semi permanent foundations and I don’t understand what’s legal and what’s not.
[…] enough simply to register and list as a Class I 510(k) exempt device (previous post with details here). The Final Classification Order is now codified in the Code of Federal Regulations (CFR) and can […]
[…] Use only FDA-cleared devices to guard against lawsuits. “In many medical device liability cases, a doctor is shielded from liability when properly using a cleared and compliant device, since the FDA review and clearance would ensure all likely hazards are controlled,” said Marc C. Sanchez, an FDA attorney who worked on Bellus Medical’s microneedling De Novo submission. “That defense is totally washed away when using an unapproved medical device.” […]
Is it true that:
1. Bellus ‘FDA Classification’ is only approved for the medical treatment of acne scars?
2. That this classification is not relivent to those doing transdermal product delivery, and devices marketed and used as such would not fall under this medical classification?
Hello Elizabeth,
It’s important to understand that there is a broad definition of what is a medical device. The FDA Microneedling Guidance outlines a number of ways in which a microneedling product could fall under the medical device regulations. In other words, the Bellus classification order is only one piece of the puzzle. If you have a microneedling device you must carefully analyze all the relevant criteria to determine classification.
When it comes to transdermal delivery what the FDA has said is that is a special type of medical device called a combination device – any topical combined with a medical device for transdermal delivery is a drug. This makes transdermal delivery a much more complicated issue.
So let me get this straight, a tattoo machine can be legally used to microneedle, just not a specific microneedling device. Correct??
Thank you, Diane Molinaro
Hello Diane,
No, what I’m saying is that a tattoo machine crosses a line and becomes a regulated medical device either due to technical features or claims or both.
Once that line is crossed then you must comply with the medical device regulations.
Hi! Unfortunately I cannot read (my phone cuts the responses off) the responses above. Do you have any info you can email me for the state of Arizona and Idaho?
Thank you very much!
So aestheticians cannot use any micro needling device at all, whether working under a medical director or not? What does it mean it’s prescription only? I’m assuming that means it can be used under a medical director or does a physician have to be the one doing the treatment???
Hello Maria,
Every state board of medicine has different rules on delegation and what constitutes the practice of medicine. Your state board of medicine can tell you more.
Since it will now be an “Rx” treatment, does this mean a physician or midlevel must administer the treatment?
Hello Erin,
Every state board of medicine has different rules on delegation and what constitutes the practice of medicine. In some cases, it is whether the device is OTC or Rx and in others about risk. Your state board of medicine can tell you more.
Does this now apply to Tattoo needling devices?
No, currently the definition of a microneedling device does not include tattooing.
In other words…Can a tattoo artist legally able to enter the skins dermis with needles able to use micro needling if they do not penetrate deeper than the dermis?
Hello Julia,
If you’re using a device for a purpose (called an intended use) covered by the Microneedling Guidance or approval order then you may be subject to FDA jurisdiction. Both the Guidance and the approval order provide criteria for claims and device design, including needle depth, to help make a determination on whether a product is a microneedling medical device.
[…] Sanchez’s post on FDA Atty to learn more about the classification order and the new risks for doctors and […]
[…] implications are now crystal clear,” said Marc C. Sanchez, an FDA attorney who worked on Bellus Medical’s microneedling De Novo submission. […]