The U.S. Food and Drug Administration (FDA) has updated its guidance on medical devices that are exempt from certain premarket notification requirements.
Issued in early June, the guidance, titled “Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements,” expands to 13 the list of medical device product codes that meet the standards for exemption under the agency’s premarket notification requirements detailed in section 510(k) of the FDA’s Safety and Innovation Act.
The updated list covers a range of devices, including ear, nose, and throat devices (such as hearing protectors and speech training aids for the hearing impaired), general and plastic surgical devices (e.g., pads, alcohol, and device disinfectants), obstetrical and gynecological devices (including fertility diagnostic devices), and toxicology devices (isoniazid test strips).
As a reminder, guidance documents issued by the FDA are not a substitute for applicable laws and regulations and are intended solely to provide information on the agency’s current perspective.
