The FDA 510(k) exemption guidance issued on June 5, 2026, added five preamendments unclassified medical device product codes to the agency’s existing policy. FDA currently believes these devices meet the standards for exemption from premarket notification requirements.
Formal exemptions have not yet occurred. Until they do—or FDA receives information that changes its current position—the agency says it does not intend to enforce 510(k) requirements for these device types and does not expect manufacturers to submit 510(k)s during this period.
FDA 510(k) Exemption Guidance: What Changed
The updated guidance adds the following five product codes:
- LDK — Optical contour sensing device
- MVV — Acupressure device
- MQZ — Nail prosthesis
- MIG — Isoniazid test strip
- LXQ — Eye cup
An Important Distinction
The guidance expresses FDA’s intent to exempt these devices; it does not itself complete the formal exemption process. Until the exemptions occur—or FDA receives information that changes its current position—the agency states that it does not intend to enforce compliance with 510(k) requirements for these device types.
FDA also states that it does not expect manufacturers to submit 510(k) premarket notifications for these devices during this period.
Other Regulatory Requirements Still Apply
The policy does not remove other applicable medical-device requirements. Depending on the product and manufacturer, these may include:
- Establishment registration and device listing
- Labeling requirements
- Quality Management System Regulation requirements
- Medical Device Reporting
- Other applicable regulatory controls
The guidance does not include combination products that may fall within the identified product codes.
FDA 510(k) Exemption Guidance: What Manufacturers Should Consider
Manufacturers should confirm their device’s product code, intended use, configuration, and applicable regulatory requirements before changing an existing submission or market-entry strategy.
RJR can help manufacturers evaluate how the FDA 510(k) exemption guidance may affect a specific device, confirm the applicable product code and device configuration, and identify the regulatory obligations that remain in effect. Start a conversation with RJR.
Source: FDA — Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements