New guidance identifies low-risk devices in eight medical specialties that will no longer require 510(k) submissions to reduce regulatory burdens.
The US Food and Drug Administration (FDA) issued guidance on June 5, 2026, announcing its intent to exempt certain unclassified medical devices from premarket notification requirements. The agency believes the identified devices meet the standards for exemption from 510(k) requirements and plans to implement a “less burdensome” policy consistent with public health.
Although the devices have not yet been formally exempted, the FDA states that it does not intend to enforce compliance with 510(k) requirements for the products identified in the guidance and does not expect manufacturers to submit premarket notifications for them.
The guidance identifies preamendment unclassified devices across eight categories, including:
- Ear, Nose, and Throat:Â Hearing protectors (insert and circumaural) and speech training aids for the hearing impaired (AC-powered, patient-contact, battery-operated, or non-patient).
- Gastroenterology-Urology:Â Hemorrhoid cushions.
- General and Plastic Surgical:Â Device disinfectant alcohol pads and nail prostheses.
- Obstetrical and Gynecological:Â Proceptive fertility diagnostic devices.
- Physical Medicine:Â Optical contour sensing devices and spine curvature monitors.
- Neurological:Â Acupressure devices.
- Toxicology:Â Isoniazid test strips.
- Ophthalmic:Â Eye cups.
The FDA clarified that while these devices may be exempt from premarket notification, manufacturers must still adhere to other statutory and regulatory requirements. These include registration and listing, labeling, medical device reporting, and good manufacturing practice requirements as defined in the Quality Management System Regulation.
The policy does not apply to combination products, such as single-entity products containing an antimicrobial agent, even if they fall within the specified product codes.
This move follows the agency’s commitment under the Medical Device User Fee Amendments and the 21st Century Cures Act to periodically exempt low-risk medical devices from premarket notification to streamline regulatory processes. The June 2026 update adds five additional preamendment unclassified devices to the list previously established in 2019.
The agency determined that implementing this guidance without prior public comment is appropriate because it presents a policy that reduces regulatory hurdles while maintaining public health standards. However, the FDA states it will still accept electronic or written comments for future consideration.
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