FDA 510(k) Glossary · regulatory

510(k) Exemption

A 510(k) exemption means a medical device is not required to submit a 510(k) premarket notification before marketing. Most Class I devices are 510(k) exempt because general controls alone are sufficient to ensure their safety. Exempt devices can still be marketed but must comply with labeling, registration, and GMP requirements.
Dataset Insight - 510k Database (166,200 records, 1980–2025)
Class I exempt devices are not required to file a 510(k) and are generally not represented in the 510k Database dataset of 166,200 clearance records.

Definition

A 510(k) exemption is a regulatory status indicating that a medical device is not required to submit a 510(k) premarket notification before marketing in the United States. Most Class I devices and some Class II devices are 510(k) exempt. The exemption status is established per product code in the FDA's device classification regulations.

What Exemption Does and Does Not Mean

A 510(k) exemption does not mean the device is unregulated. Exempt devices must still comply with all applicable general controls:

  • FDA establishment registration and device listing
  • Good Manufacturing Practices (21 CFR Part 820)
  • Labeling requirements
  • Prohibition against adulteration and misbranding
  • Medical Device Reporting (adverse event reporting)

Limitations on Exemptions

510(k) exemptions have limitations. Manufacturers may not exceed the intended use or change the technological characteristics of the exempt device type without triggering a 510(k) requirement. The FDA specifies these limitations for each exempt product code in 21 CFR.

FDA References

Related Terms

510(k) Premarket Notification - Device Classification - General Controls - Product Code

Frequently Asked Questions

A 510(k) exemption means a device is not required to submit a 510(k) premarket notification before marketing. Most Class I devices are 510(k) exempt. Exemption does not mean the device is unregulated - it still must comply with general controls including establishment registration, device listing, labeling requirements, and Good Manufacturing Practices (GMP).

The FDA's product classification database at accessdata.fda.gov shows whether each product code is 510(k) exempt. Manufacturers can search by device name or CFR regulation number. Many Class I devices have 'Exempt' listed in the premarket submission column. Even if a device type is generally exempt, specific modifications or intended uses may trigger a 510(k) requirement.

Yes. If a manufacturer makes modifications to an exempt device that significantly change its intended use or introduce new safety or effectiveness questions, a 510(k) may be required. The FDA also has the authority to remove exemptions for specific device types if safety concerns emerge.

Generally no - the 510k Database tracks devices that have submitted and received 510(k) clearances. Class I exempt devices that never filed a 510(k) are not represented in the dataset. Some formerly exempt devices that later required a 510(k) due to modifications or reclassification do appear in the dataset.