FDA Charges Ahead With MDUFA III Implementation, Despite Budget Uncertainties
This article was originally published in The Gray Sheet
Executive Summary
FDA has started carrying out its end of the medical device user fee agreement, with plans to issue several new guidance documents this fall, and the agency suggests that a short-term restriction on full user fee access should not inhibit its efforts.
You may also be interested in...
Regulatory News In Brief
FDA proposes reclassification of three devices. Group calls for release of all clinical trial data. More regulatory news.
Not-So-Happy New Year: Device Tax Not Addressed In Fiscal Cliff Law
There’s no mention of a device tax delay or repeal in the measure signed by President Obama Jan. 2, and the new law contains some Medicare payment cuts as one-year “Doc Fix” pay-fors.
Not-So-Happy New Year: Device Tax Not Addressed In Fiscal Cliff Law
There’s no mention of a device tax delay or repeal in the measure signed by President Obama Jan. 2, and the new law contains some Medicare payment cuts as one-year “Doc Fix” pay-fors.