FDA Proposes Exempting Some Class II Devices from 510(k) Requirements

The U.S. Food and Drug Administration (FDA) has proposed exempting several hundred medical devices posing moderate risk to patients from its 510(k) premarket notification procedure.

According to an analysis by the Emergo Group, the FDA’s proposal would eliminate 337 separate product codes from premarket notification requirements, about 12 percent of the approximately 2800 product codes that currently require FDA review. Specific product codes targeted for exemption include clinical chemistry or clinical toxicology products, and hematology or immunology products.

Notice of the FDA’s proposed action was published in the Federal Register on March 14th.  The proposed action is part of the agency’s effort to implement the statutory components of the 21st Century Cures Act passed in late 2016.

Importantly, the FDA notes in its proposal that exempt devices must still meet other regulatory obligations to be legally sold in the U.S., including requirements related to the maintenance of a suitable quality system.

Read the complete text of the FDA proposed exemption action as published in the Federal Register.


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