SummaryAs the medical device industry prepares for the next round of user fee negotiations, manufacturer representatives must consider the importance of FDA's approval process transparency, and regular interactive communication.
A recent independent review of FDA’s Center for Devices and Radiological Health (CDRH) reinforced the differences in the device review process between FDA offices. The analysis found that 510(k)-reviewed submissions by the Office of In Vitro Diagnostics and Radiological Health (OIR) have a shorter total review time than those reviewed by the Office of Device Evaluation (ODE). From 2012-2013, ODE’s 510(k) total review time increased from 130 to 144 days, while OIR’s time decreased from 115 to 111 days.
OIR, which is responsible for the review of in vitro diagnostics, medical imaging systems and radiation therapy systems, reviews significantly fewer submissions per year than ODE, which reviews all other devices. OIR generally reviews diagnostic devices that tend to have similar types of intended uses, allowing for linearity and some degree of repeatability in the review process; ODE, however, reviews a wide variety of devices for many disparate intended uses.
According to the review, the shorter overall review time correlates with a greater frequency of communication between OIR and Sponsors, compared to ODE. The more interactive OIR review process includes additional instances of communication (about 18 on average for OIR, compared to 13 for ODE, according to the independent review) as well as the publication of 510(k) substantial summary statements. These statements not published by ODE, provide demonstrations of successful submissions that allow manufacturers to be more informed. This results in OIR making fewer changes to submissions. The helpfulness of this practice is reinforced by results from the independent review: Additional Information Requests or Telephone Holds, which on average both increase review time, were primarily due to labeling and device description issues within ODE. In OIR these holds were entirely contributed to deficiencies in performance characteristics, rather than issues with the submission itself.
The review additionally found that ODE tends to Refuse to Accept (RTA) more initial submissions than OIR and that submissions go through more RTA rounds on average in ODE.
The results of the review show that device manufacturers can benefit from additional interaction with the Center during the review process. Efficiency can also be gained from utilizing Office-specific transparency resources which provide a window into FDA’s thinking – tools such as OIR’s substantial summary statements allow manufacturers to preemptively collect and present the data which is most important to FDA, reducing additional formal requests for information.
CDRH has published an action plan in response to the review, which includes an analysis of the various components of its device approval process, followed by implementation of new or streamlined processes and metrics to assess.
For more information on FDA communication practices, contact Lakshman at LRamamurthy@Avalere.com.