From - National Intelligence Report
The FDA has determined that 71 device types, including some diagnostic test kits, should be exempt from 510k filings. These devices are deemed "sufficiently well understood and do not present risks that…
From - National Intelligence Report
House of Representatives members Larry Bucshon, M.D. (R-IN) and Diana DeGette (D-CO) are looking for feedback on a discussion draft of legislation called the…