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# FDA Device Approvals Slowing: EP Vantage
- URL: https://www.fdaweb.com/fda-device-approvals-slowing-ep-vantage/
- Published: 2016-07-13T12:00:00.000Z
- Updated: 2026-09-14T21:14:13.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136164

EP Vantage [says](http://www.epvantage.com/Universal/View.aspx?type=Story&id=649411&isEPVantage=yes&ref=fdaweb.com) in an online post that FDA approved 19 first-time PMAs and HDEs in the first half of 2016, down slightly from the 26 approved in the comparable period in 2015\. “Perhaps the large companies have been too preoccupied with integrating their acquisitions to have put the same effort into gaining approval for their products,” the post says. “Or perhaps the venture crisis, present for several years and becoming ever more pronounced, means that smaller groups cannot get their devices to market. It is not time to panic yet, but this could be an early warning of difficulties to come.”

For 510(k) clearances, the post says, the 10 devices approved in the first half of 2016 was the same number as in the first half of 2015\. But they took longer, it adds, an average of 15.1 months, compared with 11.9 months for the first six months of last year. That was the slowest average *de novo* approval time since 2012.

“In fact, a look at *de novos* over the past decade reveals a clear pattern: the number granted rising steadily to a high of 28 in 2014 and then decreasing,” EP Vantage says. “It is easily possible that the total for 2016 will equal or surpass that of last year. The same cannot be said for PMAs and HDEs. If FDA keeps the approvals coming at a steady rate over the rest of the year we can expect just 38, which would represent a 34% drop from the 51 awarded last year.”

The post says that it seems counterintuitive that the agency would push through reforms like the Expedited Access Pathway only to permit fewer devices to reach the market. But there is always a certain amount of variability, it says, and in any case the agency can only work with what it is given. “If companies are not submitting as many applications, or if those submissions are not of sufficiently high quality, there is little the agency can do,” it adds.