CDRH Says Dozens of Applications Affected During Shutdown, and Residual Delays Likely
| Posted: 25 October 2013
By Alexander Gaffney, RF News Editor
The US' political system has seen better days, as evidenced by the recent shutdown of many government services after legislators failed to pass a budget by 1 October 2013. For the US Food and Drug Administration (FDA), which is funded through a mix of appropriated funding and industry-paid user fees, this also meant a lapse in its statutory authority to collect or spend new user fees.
And as a recent email sent to the medical device industry indicates, that will result in delays of up to three weeks for some companies.
FDA first began collecting user fees for medical devices in 2002 under the Medical Device User Fee Act (MDUFA), which was modeled closely off a similar prescription drug user fee program. Under the basic scheme, industry pays FDA a user fee for each application (premarket applications, 510(k)s, etc), and in return for the additional review resources, FDA commits to making review decisions according to set timelines.
The MDUFA program has since been renewed twice, most recently in 2012 under the Food and Drug Administration Safety and Innovation Act (FDASIA), which dramatically increased the amount of user fees paid by industry in return for a series of structural improvements within FDA's Center for Devices and Radiological Health (CDRH).
But with the shutdown of government services, FDA ran into a problem. If a device application had been submitted along with its user fee under the MDUFA program prior to 1 October 2013, it could lawfully be reviewed. However, if the user fee had not been paid as of 1 October, FDA could not review the application, even if the application had been submitted prior to that date.
The 16-day shutdown impacted "approximately 100" applications, leaving them to languish in a state of limbo. Even if FDA could legally receive the applications, it could not legally log them into its system.
What of the MDUFA Date?
Which raises an interesting question: What would the so-called MDUFA date—the date by which FDA much render an approval or clearance decision for an application—be for those applications submitted during the shutdown?
In an email to industry, FDA said all applications submitted during the 16-day shutdown would be given a receipt date of 17 October 2013—the day they could legally be logged into the system, and not the date on which they were received.
For an application submitted on 1 October 2013, that could result in a decision date nearly three weeks later than it would have otherwise received—and that's if FDA is able to process all applications without any other delays.
And delays may well be on their way. The agency said it has since been able to log all of those submissions into its system, but that it is anticipating a deluge of applications this week "due to companies that may have withheld their submissions during the shutdown or may have been waiting on small business designations."
"Although we don’t know what those numbers will be, we are prepared to log in as many submissions as possible each day," CDRH explained. "If we are unable to log in a submission on the same day it was received, we will log it in the following business day. We plan to continue this process until we return to normal submission levels."