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FDA finalizes draft guidance, exempting 120 medical device classifications from 510(k)

July 29, 2015

On July 1, 2015, FDA announced  it has updated and finalized the draft guidance issued in August 2014, entitled “Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements.”  This guidance exempts 120 medical device product codes from the PreMarket Notification (510(k)) process.  After the close of the comment period, FDA added several additional product codes to the guidance and removed two device types.

Per UL technical consultant, Jeff Rongero, “The FDA’s classification database was actually updated to reflect the exemptions while the guidance was still draft.“

Earlier in the year, FDA published Guidance exempting medical device data systems (MDDS), medical image storage devices and medical image communications devices.  In contrast to the guidance mentioned above, this Guidance indicates that FDA does not intend to enforce compliance with regulatory controls for such devices even if they exceed the exemption limitations identified under the associated 21 CFR classification regulations.  http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm401996.pdf

The Federal Register notice is at: https://www.federalregister.gov/articles/2015/07/01/2015-16150/intent-to-exempt-certain-unclassified-class-ii-and-class-i-reserved-medical-devices-from-premarket

FDA Guidance: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM407292

 

If you have any questions about FDA regulatory strategy for your device, please contact UL – [email protected] 1-888-503-5537

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