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# Input Requested on Down Classifying Certain Class 3 Devices
- URL: https://www.fdaweb.com/input-requested-on-down-classifying-certain-class-3-devices/
- Published: 2016-08-05T12:00:00.000Z
- Updated: 2026-09-14T21:21:43.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136419

FDA is seeking comments on a final set of PMA product codes that have been identified under a two-year retrospective review as candidates for reclassification, a reduction in premarket data collection through reliance on postmarket controls, or a shift in data collection from premarket to postmarket. Analyzing the Class 3 “procodes” was intended to “determine if current classifications and data collections remain appropriate for determining a reasonable assurance of safety and effectiveness,” an [agency notice](https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-18672.pdf?ref=fdaweb.com) says. “As our understanding of the technology associated with individual medical devices has increased and we have a better understanding of the risks associated with the technology of each device, our understanding of the type and amount of data that are needed to demonstrate a reasonable assurance of safety and effectiveness also evolves. We use this evolution in our understanding to require the least burdensome amount of data necessary to evaluate device effectiveness, following the least burdensome provisions of the FD&C Act (section 513(a)(3)(D)(ii).” To view a list of the procodes reviewed, [click here](http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHVisionandMission/UCM514783.pdf?ref=fdaweb.com).