2015 could see most device approvals for a decade

With the 21st Century Cures bill through the US House of Representatives and heading for the Senate, patient access to new medical technologies could soon get faster and easier. But an analysis of those devices approved in the first half of 2015 shows that it already has.

Impressively, 26 devices have been granted either a first-time premarket approval or a humanitarian device exemption by the FDA, putting this year on track to see more approvals than any time in the last decade (see graph below).

The agency’s expedited access PMA route became active in April and, while a look at the approval times shows that none of the devices approved so far this year can have been submitted via this route, this initiative is emblematic of the FDA’s determination to speed up the regulatory process.

This move has not been universally welcomed. An op-ed in the New York Times on July 17 posited that the 21st Century Cures bill could permit unsafe technologies onto the market thanks to a more relaxed attitude to clinical data.

It is interesting that this warning has been sounded by two cardiologists. The area of cardiology saw by far the most PMA and HDE approvals in the first six months, and the 11 approvals awarded to heart devices in the last six months is the same number as seen in the whole of 2014.

And as the table below shows, these approvals have come reasonably quickly. Cardiology devices were approved in an average of 15.2 months, faster than the overall average of 17.1 months. Only imaging devices and products for wound management passed through the FDA more rapidly.

The question of whether the US regulatory process is sufficiently rigorous for innovative and high-risk devices is well worth asking. But it is widely believed to be more stringent than the process by which medical devices reach market in Europe, and efforts to tighten up European regulation have met with fierce resistance by industry lobbyists and patient groups.

And it is of note that the average approval time for all the devices granted PMA or HDE was marginally longer during H1 2015 than during last year: 17.1 compared with 16.7 months.

Not surprisingly, HDEs were quicker. Humanitarian device exemption is a rare disease approval; devices to treat conditions affecting fewer than 4,000 US patients can access this route. Kaneka’s Lixelle, a blood filter used to treat a rare protein-folding condition associated with chronic kidney failure, took more than two years to gain its HDE, but Abiomed’s Impella RP right-side heart pump got its HDE after just 4.4 months.

These were the only two HDEs in H1, making the average time for these approvals 14.7 months, beating the 17.3 for PMAs alone.

But there is another route for innovative devices that is quicker still. Low-risk devices are usually cleared through the 510(k) route, but those that are too dissimilar to prior technologies to be able to use a predicate can be granted a de novo clearance.

The FDA has already undertaken to accelerate this route, just as it has with PMAs (The FDA's latest push to speed medtech approvals, August 28, 2014). But it is already no slouch: the 10 devices granted de novo clearance in H1 got it in just less than a year, on average.

De novo approvals have a relatively low bar for safety and efficacy. To be eligible a product must pose low to moderate risk with “reasonable assurance” of its safety and effectiveness. The developer must set out the device’s known risks and benefits, showing that the risks can be effectively mitigated and the effectiveness assured.

What this means in practice is that some – and this is not meant unkindly – rather odd devices have reached market via this path.

The BrainPort V100 developed by Wisconsin group Wicab is designed to help blind people with orientation and mobility. The system includes a video camera mounted on a pair of sunglasses linked to an array of electrodes that the user holds in their mouth. Pixels on the video feed are translated into electrical impulses that are felt on the tongue; according to Wicab users say this feels like tiny bubbles.

Cerebral Assessment Systems’ Cognivue is a computer-based system used to assess and monitor brain function to detect early signs of dementia. The patient sits at a computer screen and watches computer-generated displays with varying sections highlighted. They move “a one-handed steering wheel called a manipulandum” to indicate the highlighted location, giving a measure of their brain function.

The swiftest of all the de novos, though, was a world first. DexCom’s Share Direct Secondary Displays apps – one for the patient and one to be used by carers or parents – became the first apps to be specifically approved as medical devices (DexCom's FDA app nod is just in time for the Apple Watch, January 26, 2015). The products, which enable users to see a constant feed of a patient’s blood sugar levels, were cleared in January after just 1.3 months.

This timeframe is an outlier, and it is hard to say whether it is likely to be surpassed any time soon. But it would not be a surprise if the second half of the year brought even more approvals of innovative devices than the first, and 2015 set a new record.

To contact the writer of this story email Elizabeth Cairns in London at [email protected] or follow @LizEPVantage on Twitter