CFR - Code of Federal Regulations Title 21 - Food and Drug Administration
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=812.2
Mar 29, 2022 · (2) A device, other than a transitional device, introduced into commercial distribution on or after May 28, 1976, that FDA has determined to be substantially equivalent to a device in commercial distribution immediately before May 28, 1976, and that is used or investigated in accordance with the indications in the labeling FDA reviewed under ...
DA: 94 PA: 32 MOZ Rank: 8