AdvaMed outlines FDA device proposals for government shutdowns

The Advanced Medical Technology Association (AdvaMed) has proposed legislation to continue medical device reviews from the Food and Drug Administration (FDA) in the event of U.S. government shutdowns.

The legislation would allow Congress to authorise the FDA to continue processing new device applications and their associated user fees during a lapse in appropriations, and to tap into its pool of “unearned” user fees to fund device review activities during a lapse in appropriations.

The aim is for the review process to continue without interruption and would prevent the creation of any backlog.

Prior to the latest shutdown’s conclusion on 25 January, AdvaMed said: “The medical technology community is already feeling the effects of the partial government shutdown. Under current law, FDA cannot review new fee-paying medical device applications for market clearance, and, as a result, the innovation pipeline is becoming dangerously clogged.”

The latest U.S. government shutdown lasted for 35 days – the longest in U.S. government history – stemming from an impasse over funds for a wall proposed by President Trump along the U.S-Mexico border.

AdvaMed president and CEO Scott Whitaker said: “Federal law should not deny FDA access to funds that companies have already agreed to pay the agency for the express purpose of device reviews. Our legislative proposals will ensure FDA can continue doing its job during a government shutdown so that American patients can have timely access to safe and effective medical devices.

“We’re putting forth common-sense solutions to a bureaucratic obstacle that is stifling the pipeline of new medtech innovations that patients depend on. We can’t allow this situation to continue, and we want to work with Congress, FDA and other stakeholders on moving this legislative fix forward.”