On October 1st, 2013, the Government of the United States began shutting down operations due to an impasse in congress regarding government funding appropriations. Practically speaking for the medical device industry, the shutdown puts businesses, medical professionals, and, ultimately, patients in a lurch as new medical technology cannot get to market.
The FDA employs a risk classification system to ensure commercialized product is safe and effective for use. Some devices are exempt from pre-market notification or approval, while others have to send lengthy submissions for review and clearance or approval, respectively, by the Agency. As of the shutdown, the FDA’s operation is limited, per their website, to the high-risk items and submissions currently under review (provided 2013 user fees can fund the review).
A full break-down of submissions impacted can also be found here
What does all of this mean? Much to the Agency’s chagrin, reality is limited to out-of-office notices, rapidly overflowing voicemail inboxes, and an increasing regulatory absence as resources continue to be pared back. Legally, there’s nothing FDA can do about it as they do not have the ability to collect any 2014 user fees to keep these operations afloat until the legislative and executive branches of the government come to terms. Thankfully, submissions sent prior to October 1st continue to be reviewed (though, some of those might be furloughed as well due to constrained resources).
The affect of the shutdown carries over to more than just submissions. At the Regulatory Affairs Professional Society (“RAPS”) conference two weeks ago, the highly-anticipated medical device quality panel was cancelled, as well as a number of other FDA-supported seminars. All speaking engagements for the FDA have been postponed or cancelled.
Additionally, think of the glut of emails that await the FDA employees when they finally return to work; there will be a tsunami of documents looming over their return which may take months to dig out from under.
Sadly, this impasse will be shutting down progress that the FDA has so diligently fought for over the last year regarding submission review times, responsiveness, etc. The impact of this current scenario will surely be felt well into 2014 if not into 2015.
- Maria Fagan