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Q3 US Device Approvals Snapshot: Apps Up, Original PMAs Down

News article posted on 09 October 2018 on Medtech Insight
Author: David Filmore  |  Source of Original Article

Executive Summary

Mobile apps made major headway into the world of US FDA regulation in the third quarter, with de novo go-aheads for two Apple Watch heart-rhythm apps and the first FDA approval of a smartphone app to support contraception. Meanwhile, original PMA-approval volumes continue to lag in 2018. Here’s an infographic to spotlight US device approval trends during the third quarter, July through September.


Smart devices and apps have been targeting health care for years, and US FDA has been making a big push to build a framework and expertise to regulate the space. Those two lines of effort met in a big way last quarter, with the first set of high-profile direct-to-consumer mobile apps cleared by FDA.

The Apple Watch apps intended to monitor for atrial fibrillation gained FDA go-ahead in September. (Also see “FDA’s Speedy Apple Watch De Novos Raise Questions For Industry” – Medtech Insight, 24 Sep, 2018.) And the Natural Cycles app became the FDA-cleared app for birth control in August. (Also see “FDA Approves Birth Control Mobile App, Vaginal Ring ” – Medtech Insight, 10 Aug, 2018.)

Both of those approvals were controversial, but they provide insight on the types of mobile apps that will be subject to FDA-review and the approach the agency will take. (Also see “Q&A: What Do FDA’s Recent Medical App Approvals Mean For Industry?” – Medtech Insight, 30 Aug, 2018.)

The apps joined six other devices in capturing de novo classifications from FDA in the third quarter. The number of de novosgetting through FDA has increased in recent years, and 2018 has been a particularly productive year for companies pursing this route, intended for low-to-moderate risk products with no predicate device on the market. There have been 29 de novo classifications in the first nine months of 2018, well ahead of any year in recent history, according to Medtech Insight‘s Approvals Tracker.

The picture is a bit different for the regulatory pathway used for new implantables and other high-risk, novel devices. FDA has approved 22 original PMAs this year through September, well behind the pace of record-level volumes over the past three years.

The boom in de novos had been enough to balance the drop in original PMAs, keeping the overall count of “novel” device approvals (including original PMAs, panel-track PMA supplements and de novos) about even with recent high-performing years.

Check out the infographic below. For a comprehensive database of US and global device approvals, visit Medtech Insight’Approvals Tracker.

Q3 US Approvals

For Q3 global device approvals, check out the infographic below.

The third quarter of 2018 brought 60 approvals from outside the US, including 31 in Europe, according to Medtech Insight‘s Approvals Tracker. Among those approvals, six were for devices to treat coronary artery disease; the second most common indications were peripheral disease and catheter complications. Outside of Europe, India recorded the most non-US approvals in the quarter with eight.

Q3 Global Approvals

For more on Q3 global device approvals, read: Q3 Global Device Approvals Shapshot: Another Big Quarter For Coronary And Peripheral Intervention Approvals at Medtech Insight.

Author: David Filmore  |  Source of Original Article