An indefinite shutdown of the US government due to an effort by the House of Representatives to stymie healthcare reform laws has caused the Food and Drug Administration to severely limit its activities related to new medical device registrations.
According to the US Department of Health and Human Services as well as an email from the FDA, the agency will have no legal authority to accept 2014 medical device user fees or regulatory submissions for its 2014 fiscal year that require fee payments—such as most new 510(k) premarket notifications and Premarket Authorizations (PMA)—until Congress passes a Continuing Resolution to properly fund government agencies. The Obama Administration and the US Senate are requiring a “clean” government funding bill without provisions added by House Republicans to defund or delay implementation of Affordable Care Act; there are no indications yet as to when a political resolution will be reached.
The only functions the FDA is authorized to perform during the shutdown include criminal law enforcement, emergency work pertaining to human safety or property protection, and activities already funded by the 2013 Medical Device User Fee apparatus.
Emergo Group is following this issue closely, and will update readers of any developments as we learn them.