FDA published the draft guidance “Dental Curing Lights – Premarket Notification (510(k)) Submissions – Draft Guidance for Industry and Food and Drug Administration Staff,” on July 12, 2024, for feedback. Feedback needs to be submitted by September 10, 2024. The guidance provides comprehensive recommendations for 510(k) submissions of dental curing lights. The device emits non-ionizing optical radiation to photopolymerize dental restorative resins.
Key Highlights in the Guidance
The section “Premarket Submission Recommendations” from the draft guidance covers various aspects of dental curing lights, ensuring that submissions are thorough and meet regulatory standards. Here is a summary of the key points:
Device Description
Manufacturers should include a detailed description of their device. This description must cover:
- All components: Detailed labeled images and/or illustrations of each part.
- Features: Descriptions of features and materials, particularly those that come into contact with patients.
- Accessories: Descriptions of any included accessories such as filters, shields, or protective equipment.
- Power Source: Information on the power source, battery type, capacity, and electrical characteristics.
- Light Source: Details about the light source, including the number, placement, and wattage of light sources (particularly LEDs).
- Operational Modes: Descriptions of all operational modes, controls, sensors, and alarms.
Predicate Comparison
Manufacturers need to compare their device to legally marketed predicate devices. This comparison must include:
- Similarities and Differences: A clear comparison of the new device with predicate devices, including similarities and differences in design, materials, and performance.
- Substantial Equivalence: Evidence that the new device is as safe and effective as the predicate device.
Labeling
The submission should include labeling information, which consists of:
- Instructions for Use: Clear and comprehensive instructions.
- Warnings and Precautions: Necessary warnings, precautions, and contraindications.
- Performance Characteristics: Performance characteristics relevant to the safe use of the device.
Reprocessing
If the device is reusable, the manufacturer must provide detailed reprocessing instructions, ensuring the device can be safely cleaned and sterilized between uses. This should include:
- Validation of Reprocessing Procedures: Data demonstrating that the reprocessing procedures are effective and do not damage the device.
Biocompatibility
Biocompatibility testing must be conducted on all patient-contacting materials. This involves:
- Standards Compliance: Demonstrating compliance with recognized biocompatibility standards.
- Testing Results: Providing detailed results of biocompatibility tests.
Software
For devices incorporating software, the submission should include:
- Software Description: An overview of the software, including its functionality and intended use.
- Verification and Validation: Documentation of software verification and validation processes.
- Level of Concern: Identification of the level of concern for the software based on potential impacts on patient safety.
Cybersecurity
For devices that are connected to networks or other devices, manufacturers need to address cybersecurity risks by including:
- Risk Management: A description of the cybersecurity risk management processes.
- Safeguards: Details of safeguards to protect the device from cybersecurity threats.
Electrical Safety and Electromagnetic Compatibility (EMC)
Manufacturers must ensure their devices meet electrical safety and EMC standards by providing:
- Testing and Results: Data from testing conducted according to recognized standards.
Wireless Technology
For devices using wireless technology, manufacturers should provide:
- Technology Description: An explanation of the wireless technology used.
- Performance Testing: Data demonstrating the wireless performance and reliability.
Non-Clinical Performance Testing
Non-clinical performance testing must cover several aspects:
- Radiant Power Output:
It means the ability of the curing light to emit sufficient radiant power to cure dental resins. Manufacturers should provide data on the radiant power output of the device.
- Heat Generation:
It means the ability to manage heat to avoid thermal hazards. Data demonstrating that the device does not generate excessive heat during normal and single fault conditions. This includes identifying the maximum temperature of the device’s body and the distal tip.
- Depth of Cure:
It means the thickness of the dental restorative resin that the curing light can adequately cure. Data on the depth of cure after a clinically relevant curing time (typically 10 seconds), including the specific dental restorative resin tested.
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