Device approvals drop, but the FDA has a plan

Increased headcount should allow the FDA to up the number of approvals – but not quite yet.

The FDA did a pretty good job of keeping the approvals coming for medical devices during the Covid crisis. Now, however, as the pressure is easing, the agency is slowing down: only 24 innovative devices gained approval or clearance in the first half of this year, the lowest six-month total since the first half of 2013. 

Hopefully the lull should be short-lived. Having been forced in early 2021 to limit its traditional approvals to prioritise emergency authorisations for Covid diagnostics and devices, the FDA’s leadership said at the end of May that it would now accept all non-Covid IVD pre-submissions, though timelines would still be longer than usual.  

The future looks bright, then, but the present is somewhat overcast. So far this year the agency has awarded just 12 premarket approvals – the route used by high-risk devices unlike anything yet approved – and 12 de novo clearances – the pathway for similarly novel low-risk products. 

If this rate of approvals does not pick up in the second half, 2022 will see the fewest new devices hit the US market since 2013. And the slowest approvals for some time, too: the first half’s de novos were granted in an average of 13.3 months, the greatest lag between submission and approval since 2016. The PMAs were even worse, taking an astonishing 20.9 months on average.

Perhaps this last figure is not quite as bad as it seems. It is distorted somewhat by an outlier: Aveir VR, the leadless pacemaker brought to market by Abbott Laboratories after an approval process lasting six and a half years. 

In fact the submission for Aveir VR was the same one that was filed for Nanostim, the leadless pacemaker developed by St Jude Medical. That device had a number of design problems, which have subsequently been ironed out. St Jude was bought by Abbott in 2017. 

H1 2022's approvals by therapy area
Evaluate Medtech classification Number of PMAs/HDEs Avg approval time (mths) Number of de novos Avg approval time (mths)
Anaesthesia & respiratory 2 14.9 - -
Cardiology 4 33.0 - -
Endoscopy - - 1 4.9
General hospital & healthcare supply - - 1 16.0
In vitro diagnostics  2 10.3 4 17.9
Neurology 1 37.2 2 8.3
Ophthalmics - - 1 19.0
Orthopaedics 2 6.3 1 7.6
Patient monitoring - - 1 21.1
Urology 1 18.7 1 2.5
Total  12 - 12 -
Average  - 20.9 - 13.3

This analysis arguably does not give a true picture of the medtech industry’s marketed products, even in the US, however. Many in vitro diagnostics are sold in the US under Clia waivers, meaning the sites at which they are used are regulated, rather than the tests themselves, and the regulatory body is the Centers for Medicare and Medicaid, not the FDA. They would not be captured by this analysis.

An example is Guardant Health’s Shield colorectal screening test, launched in May as a lab-developed test under a Clia waiver. This is in a large pivotal trial, however, and Guardant intends to seek FDA approval in the next year or so. 

Then, of course, there are the many digital health products that also fall outside the FDA’s purview. The agency does oversee certain products, such as prescription apps. But technologies such as artificial intelligence software used to detect diseases from medical images, or telemedicine interfaces, reach the market without ever troubling the FDA’s staff.

This analysis of the FDA’s activity is a decent benchmark for the health of the more traditional end of the device market. This is looking iffy at the moment; perhaps by the end of the year the agency's efforts to increase its device throughput will allow the situation to improve. 

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