The US Food and Drug Administration (USFDA) Center for Devices and Radiological Health recently released updated guidelines for dental curing lights, dental composite resin devices, and devices intended to treat opioid use disorder (OUD).
Guidance (Final): Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder
To address the opioid epidemic, the Agency has already taken significant steps to reduce public exposure to opioids, to prevent new cases of opioid use disorder (OUD), and to assist those with the disorder with treatment.
This guidance provides recommendations for designing pivotal clinical studies for devices that treat opioid use disorder (hereafter “OUD device studies”) and supporting marketing submissions. To provide a reasonable assurance of safety and effectiveness for a device intended to treat OUD, these recommendations apply to the design and development of clinical studies.
Following the recommendations in this guidance for OUD device studies can advance the treatment of OUD by providing scientific evidence to help the FDA determine whether a device intended for OUD treatment is safe and effective.
The FDA has released a draft guidance document to aid manufacturers in preparing premarket notification (510(k)) submissions for dental curing lights. Dental curing lights are devices used to polymerize dental materials such as composite resins by emitting light in the blue spectrum. This guidance provides comprehensive recommendations to ensure these devices meet safety and efficacy standards before market entry.
By following these detailed recommendations, manufacturers can streamline the 510(k) submission process and facilitate the timely introduction of innovative dental technologies. For more detailed information, refer to the full guidance document provided by the USFDA here.
The FDA has issued a draft guidance document to assist manufacturers in preparing premarket notification (510(k)) submissions for dental composite resin devices. Dental composite resin devices are materials used in direct restorative dental procedures, such as fillings. These devices are used for dental restorations and must meet specific regulatory standards to ensure their safety and effectiveness.
The FDA provides guidance on device description, non-clinical performance testing, clinical performance testing, and labeling to support premarket submissions of dental composite resin devices. As a result of the recommendations, dental composite resin device submissions will be reviewed more consistently and efficiently, in keeping with current review practices.
For more detailed information, refer to the full guidelines provided by the USFDA through the links above.
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