FDA Commissioner Scott Gottlieb and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health (CDRH), issued a statement January 28 patting themselves on the back for speeding up approvals of new medical devices.
But did they, really?
Looking back: In the year 2009, as Barack Obama was taking over as President of the United States, the Food and Drug Administration (FDA) approved 25 new medical device applications (NDAs).
Then, in a nearly unbroken nine-year surge in approved new device applications (NDAs), the total of new devices reached 98 in 2017 (Gottlieb commenced work on May 11, 2017), and hit 106 in calendar 2018, his first full year.
Nevertheless, he and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health (CDRH), are, by implication, claiming credit, calling 2018 “a record year for device innovation.”
Strictly speaking, the “record year” (or years) for device innovation would be when those device applications were submitted, not when they came out of the FDA pipeline. Given the lag time between application and approval, that steady and steep upsurge stems almost wholly from Obama-era new device applications.
(The 25 and 106 numbers, and those in between, came under a new FDA definition which adds breakthrough devices and humanitarian device exemptions to the totals, as shown in the two side-by-side charts above. Under the old counting system, the totals would be 24 and 101.)
“The agency has also granted 112 Breakthrough Device Designation requests since the start of the program in April 2015, and, during 2018, approved or cleared nine breakthrough devices,” said Gottlieb and Shuren. That adds up to an average of 37+ per year before 2018; the statement didn’t explain the sharp 2018 decline.
The statement doesn’t mention the 82% of all new and modified devices brought to market under the 510(k) program, so we did some counts of our own after downloading the entire database of FDA 510(k) actions in recent decades:
| Year | Number of 510(k)s cleared: |
| 2009 | 3,008 |
| 2010 | 2,807 |
| 2011 | 3,126 |
| 2012 | 3,137 |
| 2013 | 3,095 |
| 2014 | 3,203 |
| 2015 | 3,024 |
| 2016 | 2,957 |
| 2017 | 3,207 |
| 2018 | 3,066 |
| 2019 | 200 (through mid-January) |
| Source: William V. Donovan | |
Our totals above differ very slightly in some years from those reported by the Emergo Group in a 2017 report, which has statistics on both the numbers and processing times for FDA 510(k)s.
According to Emergo, the time for a traditional 510(k) increased slightly from 168 calendar days in 2012 to 178 calendar days in 2016 when cleared by FDA staff, and decreased from 62 to 49 days when reviewed by third-party reviewers. So-called “abbreviated” 510(k) clearance times rose from 175 days in 2012 to 191 days in 2016. Only about 3% of 510(k)s are submitted in this category, probably because they take longer. “Special” 510(k)s, for when a modification has been made to a device, dropped a bit from 74 days in 2012 to 67 days in 2016.
Emergo hasn’t released 2017 or 2018 numbers, so we did our own calculations of the number of calendar days to decision. The totals, including all types of 510(k) submissions (traditional, traditional with third-party reviewers, abbreviated, and special), were 149 days in 2017 and 153 days in 2018. These rolled-in totals are probably little different from prior years; we didn’t break them down.
Bottom line: while the relatively tiny number of new device applications has climbed steadily—more before Gottlieb’s tenure than since—the real core of regulatory action, on 510(k)s, hasn’t changed much in either numbers cleared or average number of days since Gottlieb took over.
