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.
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.
|Identified risks||Mitigation measures|
|Adverse tissue reaction||Biocompatibility evaluation and Labeling.|
|Cross-contamination and infection||Sterilization validation, Reprocessing validation, Non-clinical performance testing, Shelf life testing, and Labeling.|
|Electrical shock or electromagnetic interference with other devices||Electromagnetic compatibility testing, Electrical safety testing, and Labeling.|
|Damage to underlying tissue including nerves and blood vessels, scarring, and hyper/hypopigmentation due to: • Exceeding safe penetration depth • Mechanical failure • Software malfunction||Non-clinical performance testing, Technological characteristics, Shelf life testing, Labeling, and Software verification, validation, and hazard analysis.|
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.
**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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