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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.

  1. Determine if your product meets the device definition based on claims and technological characteristics
  2. If classified as a device:
    • Prepare 510(k) submission
    • Demonstrate compliance with special controls
    • Identify appropriate predicate device
    • Consider Pre-Submission consultation with FDA
  3. Address all special controls including:
    • Biocompatibility testing
    • Sterilization validation
    • Performance testing
    • Software validation (if applicable)
    • Risk analysis
    • Clinical data (if required)
  4. Ensure proper documentation of:
    • Product specifications
    • Design controls
    • Risk management
    • Performance testing results
  5. 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

  • 21 CFR 878.4430: Classification regulation for microneedling devices for aesthetic use
  • 21 CFR 801.4: Intended use determination

Original guidance

  • Regulatory Considerations for Microneedling Devices Used in Aesthetic Skin Treatments
  • HTML / PDF
  • Issue date: 2020-11-10
  • Last changed date: 2020-11-09
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket, General & Plastic Surgery
  • ReguVirta summary file ID: ac6b1732943cf1d372b32f0ae7040d54
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