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.
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
Original guidance
This post is licensed under CC BY 4.0 by the author.