The article highlights the key points related to the regulatory requirements for dental curing lights intended to be marketed and used in the US.
Table of content
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a draft guidance document dedicated to the regulatory requirements for dental curing lights. Once finalized, the document will provide an overview of the applicable rules and regulations, as well as additional clarifications and recommendations to be taken into consideration by the parties involved in order to ensure compliance.
At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the existing legal framework and has been agreed with the authority in advance.
Introduction
In particular, the guidance provides recommendations for 510(k) submissions for dental curing lights. These devices emit non-ionizing optical radiation intended to photopolymerize dental restorative resins.
The FDA is issuing this draft guidance to clarify and provide recommendations for premarket submissions for dental curing lights, as well as reference relevant consensus standards. The recommendations are intended to promote consistency and facilitate the efficient review of these submissions.
When finalized, this guidance will supersede the previous guidance titled “Dental Curing Lights — Premarket Notification [510(k)] Submissions” issued on March 27, 2006. This document supplements other FDA documents regarding the specific content requirements of a premarket notification (510(k)) submission.
Additionally, the applicants should refer to 21 CFR 807.87 and FDA guidance, “Electronic Submission Template for Medical Device 510(k) Submissions”. For the current edition of the FDA-recognized consensus standard(s) referenced in this document, the interested parties should consult the FDA Recognized Consensus Standards Database.
If submitting a Declaration of Conformity to a recognized standard, it is recommended to include the appropriate supporting documentation. For more information regarding the use of consensus standards in regulatory submissions, the applicants should refer to the FDA guidance titled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices”.
Scope
The scope of this document is limited to dental curing lights regulated under 21 CFR 872.6070. Furthermore, the scope of this document does not include laser devices for polymerization such as those regulated under 21 CFR 878.4810 or under 21 CFR 872.6070 with the product code QNF, nor devices that use heat, light, or other energy sources exclusively for tooth whitening (bleaching) procedures.
Devices intended exclusively for tooth bleaching are class I exempt regulated under 21 CFR 872.6475, with product code EEG.
Premarket Submission Recommendations
In order to assist the parties involved, the document provides detailed recommendations to be followed when preparing the premarket submission, outlining the key points to be covered to ensure the accuracy and completeness of the information provided.
Device Description
It is recommended that the applicant identifies the device by the applicable regulation number and product code indicated in Section II and includes the information described below.
As part of the device description, the applicant should provide a complete description of all components, patient-contacting materials, and features of the dental curing light devices, including the following information:
- Labeled images and/or illustrations of all components that comprise the device
- Descriptions of any accessories and/or protective equipment that are packaged with the device, such as radiometers, filters, shields, light guides, and protective filter glasses
- Engineering drawings and/or schematics of the interior of the device, particularly the light assembly
- Descriptions of the power source, battery type, capacity, and electrical characteristics (e.g., frequency, voltage)
- Descriptions of the light source, number and placement of light sources (particularly for LEDs), and wattage
- Descriptions of all operational modes and any controls, sensors, or alarms
Predicate Comparison
For devices reviewed under the 510(k) process, manufacturers must compare their new device to a similar legally marketed predicate device to support its substantial equivalence (section 513(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act); 21 CFR 807.87(f)). This comparison should provide information to show how the device in question is similar to and different from the predicate. Side-by-side comparisons, whenever possible, are desirable.
The document also outlines the parameters to be used when making such a comparison, namely:
- Indications for use
- Operational modes
- Light source
- Power source
- Accessories
- Radiant power output
Labeling
The premarket notification must include proposed labeling in sufficient detail to satisfy the requirements of 21 CFR 807.87(e). Proposed labels and labeling, sufficient to describe the dental curing light, its intended use, and the directions for use must be provided.
As prescription devices, dental curing lights are exempt from the requirement to have adequate directions for lay use required under section 502(f)(1) of the FD&C Act as long as the conditions in 21 CFR 801.109 are met. For instance, to be so exempt, labeling that furnishes information for use of the prescription device must, among other things, contain adequate information for such use, including indications, effects, routes, methods, and frequency and duration of administration, and any relevant hazards, contraindications, side effects, and precautions under which practitioners licensed by law to employ the device can use the device safely and for the purposes for which it is intended (21 CFR 801.109(d)).
It is recommended that the instructions for use include the following information:
- Total radiant power output (or radiant flux) (mW) throughout the exposure cycle
- Maximum light intensity (or irradiance) (mW/cm²)
- Peak wavelength (nm)
- Radiant exposure (or optical radiation dose) output range (J/cm²)
- Recommended distance (mm) and angle (degrees) of use from the tooth surface
- Recommended curing time(s)
- Instructions for the use of disposable sleeves for non-patient contacting portions of the device, as applicable
- Instructions for the use of protective equipment such as shields, filter glasses, etc., as applicable, in accordance with the currently FDA-recognized versions of ISO 12609-1 Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications — Part 1: Specification for products and ISO 12609-2 Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications — Part 2: Guidance for use
- Instructions on how to periodically check the irradiance output
- Warnings about thermal hazards
- Reuse information as described in FDA guidance “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling”. Specifically, it is recommended that the instructions for reprocessing address disassembly, cleaning, disinfection/sterilization, and reassembly of the device
Reprocessing
Significance: Many of the patient-contacting components of dental curing lights are reused and should be adequately cleaned, disinfected, and sterilized between uses to minimize infections while preventing device degradation.
Recommendation: Instructions on how to reprocess a reusable device are critical to ensure that a device is appropriately prepared for its initial and subsequent uses. For recommendations regarding the development and validation of reprocessing instructions in the proposed device labeling, the applicant should refer to the FDA guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling”.
Conclusion
In summary, the present guidance provides comprehensive recommendations for the 510(k) submissions for dental curing lights, detailing the necessary device descriptions, predicate comparisons, labeling, and reprocessing instructions.
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