Premarket Notification Requirements for Dermabrasion Devices
This guidance assists manufacturers in submitting premarket notifications (510(k)) for dermabrasion devices intended to abrade or erode skin. It covers both manual and motorized dermabrasion devices, which are Class I devices generally exempt from 510(k) requirements unless they have different intended uses or fundamental technologies.
Recommended Actions
- Determine if 510(k) submission is required based on intended use and technology differences from legally marketed devices
- If 510(k) required, prepare comprehensive device description including materials, mode of action, and output parameters
- Develop and validate sterilization procedures and documentation
- Prepare required labeling including sterilization instructions
- For new indications:
- Design clinical study protocol
- Submit protocol to FDA for review before starting clinical trials
- Collect comparative safety and effectiveness data
- Compile all required documentation for 510(k) submission
- Ensure compliance with sterilization requirements and validation
- Maintain documentation of comparison with predicate device
Key Considerations
Clinical testing
- Clinical data required only for indications other than general dermabrasion, scar revision, and tattoo removal
- Device considered non-significant risk
- Recommended to submit study protocol to FDA before starting clinical trials
Labelling
- Must include predicate device labeling
- Must include proposed device labeling
- Must include sterilization instructions for non-sterile or reusable components
Safety
- Sterilization information must specify:
- Pre-sterilized components
- Components requiring sterilization before use
- Mode of sterilization
- Sterility assurance level (SAL)
- Validation method
Other considerations
- Device description must include:
- Material composition
- Mode of action
- Output parameters
- Comparison with predicate device
- Required documentation:
- Design Controls for Medical Device Manufacturers
- Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation
- 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 878.4800: Manual dermabrasion devices classification
- 21 CFR 878.4820: Motorized dermabrasion devices classification
- 21 CFR 878.9: Limitations of exemptions
- 21 CFR 812.3(m): Significant risk device criteria
Original guidance
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