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.
What You Need to Know? 👇
What regulatory classification applies to dermabrasion devices under FDA regulations?
Dermabrasion devices are classified as Class I devices under 21 CFR 878.4800 (manual) and 21 CFR 878.4820 (motorized). Both types were exempted from premarket notification procedures, with manual devices exempted in 1994 and motorized devices in February 1998.
When is a 510(k) premarket notification required for dermabrasion devices?
A 510(k) is required when the device has different indications than general dermabrasion, scar revision, acne scar revision, or tattoo removal; contains different output parameters; operates via different mode of action; or uses different abrasion substrate than legally-marketed devices.
What are the standard indications for use approved for dermabrasion devices?
The standard approved indications for dermabrasion devices include general dermabrasion, scar revision, acne scar revision, and tattoo removal. These are considered preamendment device indications that don’t require additional premarket notification if the device is substantially equivalent.
What essential documentation must be included in a dermabrasion device 510(k) submission?
Required documentation includes indications for use form, 510(k) summary/statement, truthful and accuracy statement, device description with schematics, sterilization information, predicate device labeling, and proposed device labeling. Clinical data may be needed for non-standard indications.
How does FDA classify dermabrasion devices regarding clinical study risk assessment?
FDA considers dermabrasion devices as non-significant risk devices since they don’t meet criteria in 21 CFR § 812.3(m). Sponsors should provide study protocols to FDA before commencing clinical trials to ensure adequate data for substantial equivalence determination.
What sterilization requirements apply to dermabrasion devices in FDA submissions?
The 510(k) must specify which components are pre-sterilized or require sterilization, the sterilization mode, sterility assurance level (SAL), and validation method. Labeling must include validated sterilization instructions for non-sterile devices or reusable components.
What You Need to Do 👇
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:
- Indications for use form
- 510(k) summary or statement
- Truthful and accuracy statement
- Device description with schematic/engineering drawing
Relevant Guidances 🔗
- 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