A new article published on Medical Device and Diagnostic Industry’s (MDDI) website by Hyman, Phelps & McNamara, P.C.’s Jeff Gibbs, Allyson Mullen, and Graematter, Inc’s Melissa Walker, shows that there is more to 510(k) review time statistics than the statistics that FDA publishes. (A shorter version of the full length article will also appear in MDDI’s magazine in early 2015.) The authors analyzed 510(k) review time data from FDA’s publicly available database using SOFIE, Graematter Inc.’s Regulatory Intelligence System. The article points out several interesting conclusions from the analysis:
- Use of the third-party review program has significantly declined, while the review times for these 510(k)s have increased.
- Contrary to expectations, there is no review-time advantage to submitting an Abbreviated 510(k) compared to a Traditional 510(k).
- Analyzing review times for specific device types can show surprising patterns. Even those devices most frequently reviewed by FDA still saw an increase in their overall review times between 2008 and 2012.
- There can be substantial jumps in average review times for certain types of products; steep declines are rarer.
Another finding is that in vitro diagnostic device (IVD) 510(k)s take significantly longer to review than 510(k)s for other types of devices. Between 2008 and 2012, the average review time for an IVD 510(k) was 183 days compared to a non-IVD 510(k), which was 127 days. This finding is of particular importance given FDA’s proposed plan to regulate laboratory developed tests (LDTs) as IVDs (see our earlier posts on this proposal). The same reviewing divisions that are already experiencing higher than average review times will begin seeing a great deal more work, if FDA’s plan to regulate LDTs is finalized. It is reasonable to conclude, in an era of fiscal cliffs and government shutdowns, that FDA will not be given a large number of resources to deal with this increased workload. IVD manufacturers have expressed concerns about the impact of LDT regulation on review times. These data suggest the concerns are well-founded.