The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) has released two new guidance documents pertaining to how the agency plans to calculate review time and goals for medical device submissions under the Medical Device User Fee Act (MDUFA), part of the FDA Safety and Innovation Act (FDASIA).
Specifically, the guidance documents reference two of the most common forms of medical device submissions: 510(k) applications, which are based on a finding of substantial equivalence to an approved predicate device, and premarket approval applications (PMAs), which are used for new or high-risk devices.
Much of both guidance documents pertains to the concept of a "review clock" established under MDUFA. While a device may take months to obtain approval from FDA, the official review time is meant to allow for FDA to stop the review clock for applications with insufficient information, filing problems or significant questions that must be answered by the sponsor.
For 510(k)s, FDA can stop the review clock if it clears the device, if it declares the device not substantially equivalent (NSE), requests additional information (AI), if it determines the company improperly used a 510(k) application, or if the company withdraws its application.
FDA said it aims to clear 65% of all 510(k) devices within 60 days in 2013, and 91% of all devices within 90 days. By 2017, MDUFA requires FDA to improve both of these metrics considerably to 95% within 60 days and 95% of the remaining applications within 90. Those times, it should be noted, are measured in FDA's calendar review times. The agency aims to clear 510(k)s in 135 calendar days on average in 2013, decreasing to 124 by 2017.
For PMAs, FDA has five options available for it to pause the review clock: issuing an approval order, issuing an approvable letter, issuing a major deficiency letter, issuing a not approvable letter and issuing a denial order. Sponsors may also withdraw a premarket approval application, which would also stop the review clock.
FDA's review times for PMAs are also aggressive, and increasingly so through 2017. Original PMAs not requiring a panel, for instance, will aim for 180 days to approval in 65% of cases in 2013, increasing to 95% by 2017. FDA will aim to process others in far shorter time, such as 90% of all supplements and real-time supplements within 90 days, increasing to 95% efficiency by 2017.
Guidance for Industry and Food and Drug Administration Staff - FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals
Guidance for Industry and Food and Drug Administration Staff - FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals