On June 5, 2026, the U.S. Food and Drug Administration (FDA) officially issued the final industry guidance, “Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements.” The update adds 5 new product codes, bringing the total to 13 categories of low-risk medical devices exempt from 510(k) premarket notification requirements. The new policy will be fully implemented from this week.
Manufacturers of eligible devices will no longer need to invest the time and resources required to prepare and submit a traditional 510(k) premarket notification in order to enter the U.S. market in compliance with FDA requirements.
1. Policy Background: Regulatory Relief for Established, Low-Risk Devices
The exemptions apply to certain unclassified medical devices that were commercially distributed in the United States before the enactment of the Medical Device Amendments of 1976 but had not been formally classified as Class I or Class II devices.
Based on long-term safety data and regulatory experience, the FDA determined that these devices have established clinical applications and extremely low rates of adverse events. Therefore, a 510(k) substantial equivalence review is not considered necessary to provide reasonable assurance of their safety and effectiveness.
The update is intended to further streamline market access for low-risk medical devices while maintaining appropriate safety controls, reducing regulatory burdens for manufacturers, particularly small and medium-sized enterprises seeking to enter the U.S. market.
2. Complete List of Medical Devices Covered by the Exemption
The following devices are unclassified devices prior to the regulatory amendment. The FDA intends to exempt medical devices under the corresponding product codes from the 510(k) premarket notification requirement:
Ear, Nose and Throat Devices
- EWD – Hearing Protection Device, Insert
- EWE – Hearing Protection Device, Circumaural
- LEZ – Electrically Powered, Contact-Type Assistive Device for Speech Training of Persons with Hearing Impairment
- LFA – Battery-Powered, Non-Contact-Type Assistive Device for Speech Training of Persons with Hearing Impairment
Gastroenterology-Urology Devices
- LRL – Hemorrhoidal Care Pad
General and Plastic Surgery Devices
- LKB – Disinfectant Swab for Device Surface Disinfection
- MQZ – Nail Prosthesis
Obstetrical and Gynecological Devices
- LHD – Fertility Diagnostic Device for Prediction of Conception
Physical Medicine and Rehabilitation Devices
- LDK – Optical Body Contour/Posture Sensing Device
- LZW – Scoliosis Measurement and Monitoring Device
Neurological Devices
- MVV – Acupoint Pressure Therapy Device
Toxicology Testing Devices
- MIG – Isoniazid Test Strip
Ophthalmic Devices
- LXQ – Eye Wash Cup
3. Key Takeaways for Manufacturers
The issuance of this guidance means that the above devices can potentially avoid the traditional 510(k) premarket notification process, which can involve an average review period of approximately 90 days.
For eligible products, manufacturers may also avoid the associated FDA submission fees and certain third-party consulting costs. Depending on the product and regulatory strategy, this may substantially reduce the cost and time required for U.S. market entry.
However, manufacturers should carefully distinguish between 510(k) exemption and overall FDA compliance.
The exemption only concerns the premarket notification requirement under Section 510(k). It does not exempt manufacturers from other applicable statutory and regulatory obligations, including but not limited to:
- Establishment registration
- Medical device listing
- Labeling requirements
- Quality management system and applicable manufacturing requirements
- Medical device reporting and adverse event reporting
- Other applicable FDA regulatory requirements
Therefore, manufacturers should not interpret the 510(k) exemption as a complete exemption from FDA regulation.
Conclusion
The FDA’s latest update represents an important regulatory development for manufacturers of established, low-risk medical devices. By removing the 510(k) premarket notification requirement for eligible unclassified devices, the FDA has further streamlined the U.S. market access pathway for these products.
For manufacturers, the key is to first confirm whether the product and its specific product code fall within the scope of the exemption, and then assess the remaining FDA registration, listing, labeling, quality system and post-market compliance requirements.
A 510(k) exemption may simplify the market entry process, but it does not mean “no FDA compliance.” Manufacturers should conduct a comprehensive regulatory assessment before launching the product in the United States.