Last week (26 June, 2023) the United States Food & Drug Administration's Center for Devices and Radiological Health released a draft guidance on "Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder".
In order to decrease unnecessary exposure to opioids, prevent new cases of opioid use disorder (OUD), and support the treatment of those with OUD, the US Food and Drug Administration (FDA) has taken significant steps. The opioid overdose crisis is a serious and complex issue facing the United States.
The draft guidance offers suggestions for the structure of pivotal clinical trials involving devices intended for treating Opioid Use Disorder (OUD) and used to support marketing applications. These suggestions pertain to the design and development of clinical studies, aiming to ensure the device's safety and effectiveness when used to treat OUD.
This guidance applies to pivotal clinical studies of safety and effectiveness for devices intended to treat OUD that support marketing submissions. Sponsors and investigators can use the principles discussed in this guidance to design studies that can provide reasonable assurances of a device's safety and effectiveness in treating OUD.
Hydrogen peroxide-based contact lens care products, as well as multipurpose products, clean and disinfect contact lenses by removing trapped debris, proteins, fatty deposits, and microorganisms.
The purpose of this final guidance from the FDA is to offer labeling recommendations for hydrogen peroxide-based contact lens care products (HPCPs) that are included in premarket notification (510(k)) submissions.
These labeling recommendations hold significant importance due to the occurrence of severe eye injuries associated with the misuse of these devices. This guidance can aid manufacturers in providing specific risk information and usage instructions for hydrogen peroxide-based contact lens care products (HPCPs) when used with the user's prescribed contact lenses.
The primary goal of these labeling recommendations is to encourage the safe and effective utilization of HPCPs while ensuring that consumers receive and comprehend essential information about the advantages and potential risks linked to the device's use.
To see an example of the Package Insert, click this LINK.
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