Regulatory Considerations for Microneedling Devices Used in Aesthetic Skin Treatments
This guidance addresses microneedling products with arrays of needles, micro-protrusion tips, or pins used for skin treatments. It covers both manual and motorized devices used for exfoliation, improving skin appearance, treating scars, wrinkles, and other skin conditions. The guidance excludes combination products, acupuncture needles, hypodermic needles, tattoo machine needles, energy-emitting needle probes, and dermabrasion devices.
What You Need to Know? 👇
What determines if a microneedling product is classified as a medical device?
A microneedling product is classified as a medical device if it’s intended to diagnose, cure, mitigate, treat, or prevent disease, or affect the body’s structure or function. Key factors include claims about penetrating living skin layers, treating conditions like scars or wrinkles, and technological features enabling deep skin penetration.
What regulatory pathway do microneedling devices for aesthetic use follow?
Microneedling devices for aesthetic use are classified as Class II devices under 21 CFR 878.4430. They require premarket notification (510(k)) submission demonstrating substantial equivalence to a legally marketed predicate device and compliance with special controls outlined in the classification regulation.
What are the key differences between microneedling and dermabrasion devices?
Microneedling devices use needle substrates to puncture skin, while dermabrasion devices use abrasive substrates like brushes and burrs to remove skin layers via shear forces. They have different technological characteristics, modes of action, and raise different safety and effectiveness questions despite potentially similar intended uses.
What clinical data might be required for microneedling device 510(k) submissions?
Clinical data may be required for devices with new indications or different technological characteristics. Studies should include representative subjects, safety data on infection and tissue damage risks, validated effectiveness endpoints aligned with intended use, and appropriate follow-up periods for short and long-term assessment.
Which microneedling products are NOT considered medical devices?
Microneedling products that only facilitate skin exfoliation (stratum corneum removal), improve skin appearance, or provide smoother look and feel without penetrating living skin layers are generally not devices. These products don’t affect body structure or function and make no medical claims.
What special controls apply to Class II microneedling devices for aesthetic use?
Special controls under 21 CFR 878.4430(b)(1)-(10) address risks including adverse tissue reactions, cross-contamination, infection, electrical shock, electromagnetic interference, and tissue damage. These controls mitigate risks from exceeding safe penetration depth, mechanical failure, or software malfunction through specific design and testing requirements.
What You Need to Do 👇
Recommended Actions
- Determine if your product meets the device definition based on claims and technological characteristics
- If classified as a device:
- Prepare 510(k) submission
- Demonstrate compliance with special controls
- Identify appropriate predicate device
- Consider Pre-Submission consultation with FDA
- Address all special controls including:
- Biocompatibility testing
- Sterilization validation
- Performance testing
- Software validation (if applicable)
- Risk analysis
- Clinical data (if required)
- Ensure proper documentation of:
- Product specifications
- Design controls
- Risk management
- Performance testing results
- Maintain compliance with general controls including:
- Registration and listing
- Quality System Regulation
- Medical Device Reporting
- Labeling requirements
Key Considerations
Clinical testing
- Clinical study protocol should include representative patient population
- Safety data collection required for infection, nerve/blood vessel damage, scarring, pigmentation issues
- Effectiveness endpoints should align with intended use
- Appropriate follow-up period to assess short and long-term performance
Software
- Special controls required for software-controlled devices to prevent malfunction
Biocompatibility
- Must demonstrate biocompatibility and address adverse tissue reactions
Safety
- Must address cross-contamination and infection risks
- Must prevent electrical shock and electromagnetic interference
- Must prevent tissue damage through safe penetration depth control
- Must ensure mechanical reliability
Other considerations
- Product design and technological characteristics assessment required
- Needle length, arrangement, and sharpness evaluation needed
- Control mechanisms for manual/motorized needle movement and penetration depth
- Classification as Class II device for aesthetic use under 21 CFR 878.4430
- 510(k) submission required demonstrating substantial equivalence
Relevant Guidances 🔗
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Content of Premarket Submissions for Device Software Functions
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
- Refuse to Accept Policy for 510k Submissions: Minimum Threshold Requirements for Administrative and Technical Review
Related references and norms 📂
- 21 CFR 878.4430: Classification regulation for microneedling devices for aesthetic use
- 21 CFR 801.4: Intended use determination