The changes proposed in three new draft guidances aim to speed up the process and place less emphasis on older predicate products.
As of October 1, medical device makers must include information about their products’ vulnerabilities when seeking premarket authorization.
The recently proposed TCET rule appears to be too stringent to significantly hasten the Medicare coverage process for device makers.
Recently proposed rule seems too stringent to reduce the lag between FDA approval and Medicare coverage.
Congress brings back controversial Trump plan scrapped by the Biden administration.